{"id":36452,"date":"2024-01-17T08:11:53","date_gmt":"2024-01-17T08:11:53","guid":{"rendered":"https:\/\/www.process.st\/templates\/quality-system-medical-device-template\/"},"modified":"2024-08-13T12:03:09","modified_gmt":"2024-08-13T12:03:09","slug":"quality-system-medical-device-template","status":"publish","type":"post","link":"https:\/\/www.process.st\/templates\/quality-system-medical-device-template\/","title":{"rendered":"Quality System Medical Device Template"},"content":{"rendered":"\n<section id=\"identify-the-type-and-classification-of-the-medical-device\">\n <h2>Identify the type and classification of the medical device<\/h2>\n <div class=\"image-content\">\n  <figure>\n   <a href=\"https:\/\/ps-attachments.s3.amazonaws.com\/5ce3300e-f132-48ff-9b29-b8ae45d1b4aa\/gmRzrFyiFyu5R5oD_yhAaA.png\" alt=\"Identify the type and classification of the medical device\" target=\"_blank\" rel=\"noopener\"> <img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/ps-attachments.s3.amazonaws.com\/5ce3300e-f132-48ff-9b29-b8ae45d1b4aa\/gmRzrFyiFyu5R5oD_yhAaA.png\"> <\/a><!-- No caption -->\n  <\/figure>\n <\/div>\n <div class=\"text-content\">\n  In this task, you will identify the specific type and classification of the medical device. This information is crucial to ensure compliance with regulations and standards. By accurately identifying the device type and classification, you can proceed with the appropriate regulatory pathway. Consider the device's intended use, components, and potential risks. What resources or tools will you need to complete this task? What challenges might you encounter, and how can you overcome them?\n <\/div>\n <div class=\"select-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Device type <\/label> <select disabled class=\"form-control\"> <option value=\"An option will be selected here\">An option will be selected here<\/option> <\/select>\n  <\/div>\n  <ul class=\"items\">\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      1\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Diagnostic equipment\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      2\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Implantable device\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      3\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Therapeutic device\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      4\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Monitoring device\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      5\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Surgical instrument\n    <\/div><\/li>\n  <\/ul>\n <\/div>\n <div class=\"select-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Classification <\/label> <select disabled class=\"form-control\"> <option value=\"An option will be selected here\">An option will be selected here<\/option> <\/select>\n  <\/div>\n  <ul class=\"items\">\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      1\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Class I\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      2\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Class IIa\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      3\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Class IIb\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      4\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Class III\n    <\/div><\/li>\n  <\/ul>\n <\/div>\n<\/section>\n<section id=\"define-the-intended-use-of-the-medical-device\">\n <h2>Define the intended use of the medical device<\/h2>\n <div class=\"text-content\">\n  In this task, you will define the intended use of the medical device. Clearly outlining the device's purpose and target users is essential for regulatory compliance and effective communication with stakeholders. Consider the medical condition or ailment the device aims to address, its potential benefits and risks, and any limitations. How will this information impact subsequent stages of the quality system? What challenges might you encounter when defining the intended use, and how can you address them?\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Intended use <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Target users <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Potential benefits <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Potential risks <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Limitations <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n<\/section>\n<section id=\"perform-risk-assessment-of-the-medical-device\">\n <h2>Perform risk assessment of the medical device<\/h2>\n <div class=\"text-content\">\n  In this task, you will perform a comprehensive risk assessment of the medical device. This involves identifying potential hazards, assessing their severity and probability of occurrence, and implementing appropriate risk mitigation measures. Consider both inherent and foreseeable risks associated with the device's design, materials, and manufacturing processes. What methodologies or tools will you use for risk assessment? How will you document the results and any actions taken?\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Potential hazards <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"select-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Severity <\/label> <select disabled class=\"form-control\"> <option value=\"An option will be selected here\">An option will be selected here<\/option> <\/select>\n  <\/div>\n  <ul class=\"items\">\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      1\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     1\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      2\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     2\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      3\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     3\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      4\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     4\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      5\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     5\n    <\/div><\/li>\n  <\/ul>\n <\/div>\n <div class=\"select-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Probability of occurrence <\/label> <select disabled class=\"form-control\"> <option value=\"An option will be selected here\">An option will be selected here<\/option> <\/select>\n  <\/div>\n  <ul class=\"items\">\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      1\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     1\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      2\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     2\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      3\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     3\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      4\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     4\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      5\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     5\n    <\/div><\/li>\n  <\/ul>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Risk mitigation measures <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"file-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Attachments <\/label>\n   <div class=\"file-container\">\n    <button type=\"button\" disabled class=\"btn btn-default\"> <i class=\"fa fa-upload btn-icon\"><\/i> File will be uploaded here <\/button>\n   <\/div>\n  <\/div>\n <\/div>\n<\/section>\n<section id=\"approval-risk-assessment\">\n <h2>Approval: Risk Assessment<\/h2>\n <div class=\"approval-content\">\n  <div class=\"header\">\n   <div class=\"list-title\">\n    Will be submitted for approval:\n   <\/div>\n  <\/div>\n  <div class=\"approval-rule-subject-tasks-list\">\n   <ul class=\"list\">\n    <li>\n     <div class=\"approval-rule-subject-tasks-list-item\">\n      <div class=\"item\">\n       <div class=\"container\">\n        <span class=\"title\">Perform risk assessment of the medical device<\/span>\n        <div class=\"body\">\n         Will be submitted\n        <\/div>\n       <\/div>\n      <\/div>\n     <\/div><\/li>\n   <\/ul>\n  <\/div>\n <\/div>\n<\/section>\n<section id=\"develop-a-design-and-development-plan\">\n <h2>Develop a design and development plan<\/h2>\n <div class=\"text-content\">\n  In this task, you will develop a detailed design and development plan for the medical device. This plan will outline the steps and timelines for designing, prototyping, validating, and refining the device. Consider the necessary resources, expertise, and budget required for each stage. How will you ensure compliance with relevant regulations and standards? What challenges might you face during the design and development process, and how will you overcome them?\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Stages of design and development <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"date-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Timeline <\/label>\n   <div class=\"date-container\">\n    <button type=\"button\" disabled class=\"btn btn-default\"> <i class=\"fa fa-calendar btn-icon\"><\/i> Date will be set here <\/button>\n   <\/div>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Resources and budget <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Compliance measures <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"multi-select-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Important tasks <\/label>\n  <\/div>\n  <ul class=\"items\">\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      1\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Design concept creation\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      2\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Prototyping\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      3\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Verification and validation\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      4\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Design review\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      5\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Iterative refinements\n    <\/div><\/li>\n  <\/ul>\n <\/div>\n<\/section>\n<section id=\"prepare-technical-documentation\">\n <h2>Prepare technical documentation<\/h2>\n <div class=\"text-content\">\n  In this task, you will prepare comprehensive technical documentation for the medical device. This documentation is essential for demonstrating compliance, facilitating review by regulatory authorities, and ensuring product safety and effectiveness. Consider including information such as device specifications, design rationale, risk assessment results, test protocols, and validation reports. How will you organize and structure the technical documentation? What challenges might you encounter when preparing the documentation, and how can you address them?\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Device specifications <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Design rationale <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Risk assessment results <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Test protocols <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Validation reports <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n<\/section>\n<section id=\"conduct-preclinical-assessments\">\n <h2>Conduct pre-clinical assessments<\/h2>\n <div class=\"text-content\">\n  In this task, you will conduct pre-clinical assessments of the medical device to evaluate its safety, performance, and functionality. These assessments serve as a crucial step before proceeding to clinical evaluations. Consider conducting laboratory experiments, animal studies, or computer simulations to gather relevant data. How will you design and execute the pre-clinical assessments? What challenges might you encounter during this stage, and how can you overcome them?\n <\/div>\n <div class=\"multi-select-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Pre-clinical assessment tasks <\/label>\n  <\/div>\n  <ul class=\"items\">\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      1\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Laboratory experiments\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      2\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Animal studies\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      3\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Computer simulations\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      4\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Data collection and analysis\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      5\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Report generation\n    <\/div><\/li>\n  <\/ul>\n <\/div>\n<\/section>\n<section id=\"approval-preclinical-assessments\">\n <h2>Approval: Pre-clinical Assessments<\/h2>\n <div class=\"approval-content\">\n  <div class=\"header\">\n   <div class=\"list-title\">\n    Will be submitted for approval:\n   <\/div>\n  <\/div>\n  <div class=\"approval-rule-subject-tasks-list\">\n   <ul class=\"list\">\n    <li>\n     <div class=\"approval-rule-subject-tasks-list-item\">\n      <div class=\"item\">\n       <div class=\"container\">\n        <span class=\"title\">Conduct pre-clinical assessments<\/span>\n        <div class=\"body\">\n         Will be submitted\n        <\/div>\n       <\/div>\n      <\/div>\n     <\/div><\/li>\n   <\/ul>\n  <\/div>\n <\/div>\n<\/section>\n<section id=\"plan-and-conduct-clinical-evaluations\">\n <h2>Plan and conduct clinical evaluations<\/h2>\n <div class=\"text-content\">\n  In this task, you will plan and conduct clinical evaluations of the medical device to assess its safety and performance in a real-world setting. These evaluations involve human subjects and require strict adherence to ethical standards and regulatory requirements. Consider designing clinical protocols, recruiting participants, and collecting relevant data. How will you ensure compliance with ethical standards and obtain necessary approvals? What challenges might you face during the clinical evaluations, and how will you address them?\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Clinical protocols <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Participant recruitment plan <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Data collection methods <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Ethical considerations <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"multi-select-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Important tasks <\/label>\n  <\/div>\n  <ul class=\"items\">\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      1\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Obtaining ethical approvals\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      2\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Participant recruitment\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      3\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Informed consent process\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      4\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Data collection and analysis\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      5\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Adverse event monitoring\n    <\/div><\/li>\n  <\/ul>\n <\/div>\n<\/section>\n<section id=\"prepare-a-clinical-evaluation-report\">\n <h2>Prepare a clinical evaluation report<\/h2>\n <div class=\"text-content\">\n  In this task, you will prepare a comprehensive clinical evaluation report for the medical device. This report summarizes the results of the clinical evaluations and provides evidence of the device's safety and performance. Consider including details of the study design, participant demographics, data analysis, and conclusions. How will you structure and organize the clinical evaluation report? What challenges might you encounter when compiling the report, and how can you overcome them?\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Study design <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Participant demographics <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Data analysis <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Conclusions <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"file-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Attachments <\/label>\n   <div class=\"file-container\">\n    <button type=\"button\" disabled class=\"btn btn-default\"> <i class=\"fa fa-upload btn-icon\"><\/i> File will be uploaded here <\/button>\n   <\/div>\n  <\/div>\n <\/div>\n<\/section>\n<section id=\"approval-clinical-evaluation-report\">\n <h2>Approval: Clinical Evaluation Report<\/h2>\n <div class=\"approval-content\">\n  <div class=\"header\">\n   <div class=\"list-title\">\n    Will be submitted for approval:\n   <\/div>\n  <\/div>\n  <div class=\"approval-rule-subject-tasks-list\">\n   <ul class=\"list\">\n    <li>\n     <div class=\"approval-rule-subject-tasks-list-item\">\n      <div class=\"item\">\n       <div class=\"container\">\n        <span class=\"title\">Plan and conduct clinical evaluations<\/span>\n        <div class=\"body\">\n         Will be submitted\n        <\/div>\n       <\/div>\n      <\/div>\n     <\/div><\/li>\n    <li>\n     <div class=\"approval-rule-subject-tasks-list-item\">\n      <div class=\"item\">\n       <div class=\"container\">\n        <span class=\"title\">Prepare a clinical evaluation report<\/span>\n        <div class=\"body\">\n         Will be submitted\n        <\/div>\n       <\/div>\n      <\/div>\n     <\/div><\/li>\n   <\/ul>\n  <\/div>\n <\/div>\n<\/section>\n<section id=\"prepare-labeling-information\">\n <h2>Prepare labeling information<\/h2>\n <div class=\"text-content\">\n  In this task, you will prepare labeling information for the medical device. Labeling includes instructions for use, warnings, precautions, and any additional information necessary for safe and effective device utilization. Consider the target users, regulatory requirements, and readability of the labeling information. How will you ensure clarity and accuracy in the labeling? What challenges might you encounter during the preparation of labeling information, and how can you address them?\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Instructions for use <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Warnings and precautions <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Additional information <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"select-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Language <\/label> <select disabled class=\"form-control\"> <option value=\"An option will be selected here\">An option will be selected here<\/option> <\/select>\n  <\/div>\n  <ul class=\"items\">\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      1\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     English\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      2\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Spanish\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      3\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     French\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      4\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     German\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      5\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Japanese\n    <\/div><\/li>\n  <\/ul>\n <\/div>\n<\/section>\n<section id=\"create-device-master-record\">\n <h2>Create device master record<\/h2>\n <div class=\"text-content\">\n  In this task, you will create a device master record (DMR) for the medical device. The DMR serves as a centralized repository of information related to the device, including specifications, manufacturing processes, and quality control procedures. Consider including details such as component specifications, assembly instructions, and inspection criteria. How will you organize and maintain the DMR? What challenges might you encounter when creating the DMR, and how can you overcome them?\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Component specifications <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Assembly instructions <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Quality control procedures <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Inspection criteria <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"file-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Attachments <\/label>\n   <div class=\"file-container\">\n    <button type=\"button\" disabled class=\"btn btn-default\"> <i class=\"fa fa-upload btn-icon\"><\/i> File will be uploaded here <\/button>\n   <\/div>\n  <\/div>\n <\/div>\n<\/section>\n<section id=\"prepare-manufacturing-information\">\n <h2>Prepare manufacturing information<\/h2>\n <div class=\"text-content\">\n  In this task, you will prepare detailed manufacturing information for the medical device. This information includes instructions for production, quality control measures, and equipment specifications. Consider the manufacturing processes, materials, and safety requirements. How will you ensure consistency and traceability in the manufacturing information? What challenges might you encounter when preparing the manufacturing information, and how can you address them?\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Production instructions <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Quality control measures <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Equipment specifications <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Safety requirements <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"file-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Attachments <\/label>\n   <div class=\"file-container\">\n    <button type=\"button\" disabled class=\"btn btn-default\"> <i class=\"fa fa-upload btn-icon\"><\/i> File will be uploaded here <\/button>\n   <\/div>\n  <\/div>\n <\/div>\n<\/section>\n<section id=\"perform-testing-on-final-device\">\n <h2>Perform testing on final device<\/h2>\n <div class=\"text-content\">\n  In this task, you will perform testing on the final medical device to ensure its safety, reliability, and compliance with specifications. Testing may include functional tests, performance evaluations, and durability assessments. Consider using appropriate test methods and equipment. How will you document the test results and any necessary corrective actions? What challenges might you face during the testing process, and how will you overcome them?\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Test methods <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Test equipment <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Test results <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Corrective actions <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"file-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Attachments <\/label>\n   <div class=\"file-container\">\n    <button type=\"button\" disabled class=\"btn btn-default\"> <i class=\"fa fa-upload btn-icon\"><\/i> File will be uploaded here <\/button>\n   <\/div>\n  <\/div>\n <\/div>\n<\/section>\n<section id=\"approval-testing-results\">\n <h2>Approval: Testing Results<\/h2>\n <div class=\"approval-content\">\n  <div class=\"header\">\n   <div class=\"list-title\">\n    Will be submitted for approval:\n   <\/div>\n  <\/div>\n  <div class=\"approval-rule-subject-tasks-list\">\n   <ul class=\"list\">\n    <li>\n     <div class=\"approval-rule-subject-tasks-list-item\">\n      <div class=\"item\">\n       <div class=\"container\">\n        <span class=\"title\">Perform testing on final device<\/span>\n        <div class=\"body\">\n         Will be submitted\n        <\/div>\n       <\/div>\n      <\/div>\n     <\/div><\/li>\n   <\/ul>\n  <\/div>\n <\/div>\n<\/section>\n<section id=\"prepare-final-documentation-for-submission\">\n <h2>Prepare final documentation for submission<\/h2>\n <div class=\"text-content\">\n  In this task, you will prepare the final documentation required for submission to the regulatory body. This documentation should include all relevant information regarding the medical device, its design, manufacturing, testing, and clinical evaluations. Consider organizing the documentation in a clear and concise manner. How will you ensure completeness and accuracy in the final documentation? What challenges might you encounter during the preparation of the final documentation, and how can you address them?\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Design documentation <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Manufacturing documentation <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Testing documentation <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Clinical evaluation documentation <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"file-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Attachments <\/label>\n   <div class=\"file-container\">\n    <button type=\"button\" disabled class=\"btn btn-default\"> <i class=\"fa fa-upload btn-icon\"><\/i> File will be uploaded here <\/button>\n   <\/div>\n  <\/div>\n <\/div>\n<\/section>\n<section id=\"submit-to-regulatory-body\">\n <h2>Submit to regulatory body<\/h2>\n <div class=\"text-content\">\n  In this task, you will submit the final documentation to the regulatory body for review and approval. This step is crucial for obtaining the necessary certifications and authorizations to market and distribute the medical device. Consider following the regulatory body's submission guidelines and addressing any additional requirements. How will you track the submission progress and communicate with the regulatory body? What challenges might you encounter during the submission process, and how can you overcome them?\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Submission guidelines <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Additional requirements <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Submission tracking <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"members-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Regulatory contact <\/label> <select disabled class=\"form-control\"> <option value=\"A member or group will be selected here\">A member or group will be selected here<\/option> <\/select>\n  <\/div>\n <\/div>\n <div class=\"email-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Regulatory contact email <\/label> <input type=\"text\" placeholder=\"Something will be typed here...\" disabled class=\"form-control\">\n  <\/div>\n <\/div>\n<\/section>\n<section id=\"approval-regulatory-submission\">\n <h2>Approval: Regulatory Submission<\/h2>\n <div class=\"approval-content\">\n  <div class=\"header\">\n   <div class=\"list-title\">\n    Will be submitted for approval:\n   <\/div>\n  <\/div>\n  <div class=\"approval-rule-subject-tasks-list\">\n   <ul class=\"list\">\n    <li>\n     <div class=\"approval-rule-subject-tasks-list-item\">\n      <div class=\"item\">\n       <div class=\"container\">\n        <span class=\"title\">Prepare final documentation for submission<\/span>\n        <div class=\"body\">\n         Will be submitted\n        <\/div>\n       <\/div>\n      <\/div>\n     <\/div><\/li>\n    <li>\n     <div class=\"approval-rule-subject-tasks-list-item\">\n      <div class=\"item\">\n       <div class=\"container\">\n        <span class=\"title\">Submit to regulatory body<\/span>\n        <div class=\"body\">\n         Will be submitted\n        <\/div>\n       <\/div>\n      <\/div>\n     <\/div><\/li>\n   <\/ul>\n  <\/div>\n <\/div>\n<\/section>\n<section id=\"monitor-postmarket-surveillance\">\n <h2>Monitor post-market surveillance<\/h2>\n <div class=\"text-content\">\n  In this task, you will establish a system for post-market surveillance of the medical device. This is essential to ensure ongoing safety and performance monitoring, identify and address any adverse events or issues that may arise after the device is released to the market. Consider implementing a complaint handling process, conducting periodic risk assessments, and monitoring relevant feedback from users and healthcare professionals. How will you effectively track and analyze post-market data? What challenges might you face during post-market surveillance, and how will you mitigate them?\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Complaint handling process <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Periodic risk assessments <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Feedback analysis <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"textarea-field-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Adverse event reporting <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea>\n  <\/div>\n <\/div>\n <div class=\"multi-select-content form-field-content\">\n  <div class=\"form-group\">\n   <label> Monitoring tasks <\/label>\n  <\/div>\n  <ul class=\"items\">\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      1\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Complaint analysis\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      2\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Risk assessment\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      3\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Adverse event reporting\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      4\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     User feedback analysis\n    <\/div><\/li>\n   <li class=\"item\">\n    <div class=\"step-number-container\">\n     <div class=\"step-number\">\n      5\n     <\/div>\n    <\/div>\n    <div class=\"step-checkbox-container\">\n     <div class=\"step-checkbox\"><\/div>\n    <\/div>\n    <div class=\"item-name-static\">\n     Regulatory reporting\n    <\/div><\/li>\n  <\/ul>\n <\/div>\n<\/section>\n","protected":false},"excerpt":{"rendered":"<p>Identify the type and classification of the medical device In this task, you will identify the specific type and classification of the medical device. This information is crucial to ensure compliance with regulations and standards. By accurately identifying the device type and classification, you can proceed with the appropriate regulatory pathway. Consider the device's intended [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"ep_exclude_from_search":false,"cover_icon_emoji":"\ud83d\udd2c","cover_icon_url":"","tasks_count":"20","template_description":"A comprehensive workflow for assessing, testing, and approving medical devices, ensuring top quality and full regulatory compliance.","template_id":"uh7a0qME98XlaovrPdBBNg","task_0":"Identify the type and classification of the medical device","task_slug_0":"identify-the-type-and-classification-of-the-medical-device","task_1":"Define the intended use of the medical device","task_slug_1":"define-the-intended-use-of-the-medical-device","task_2":"Perform risk assessment of the medical device","task_slug_2":"perform-risk-assessment-of-the-medical-device","task_3":"Approval: Risk 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