{"id":32676,"date":"2023-10-18T03:08:12","date_gmt":"2023-10-18T03:08:12","guid":{"rendered":"https:\/\/www.process.st\/templates\/fda-audit-checklist-for-medical-devices\/"},"modified":"2024-03-05T14:39:24","modified_gmt":"2024-03-05T14:39:24","slug":"fda-audit-checklist-for-medical-devices","status":"publish","type":"post","link":"https:\/\/www.process.st\/templates\/fda-audit-checklist-for-medical-devices\/","title":{"rendered":"FDA Audit Checklist for Medical Devices"},"content":{"rendered":"\n<section id=\"identify-the-medical-devices-and-their-classifications\"> \n <h2>Identify the medical devices and their classifications<\/h2>\n <div class=\"text-content\">\n   In this task, you will identify the medical devices used by your organization and determine their classifications. This is crucial as different device classifications have varying regulatory requirements and guidelines. By accurately identifying the devices and their classifications, you can ensure proper adherence to the applicable regulations and streamline the audit process. Who in your organization is responsible for determining device classifications? What challenges might arise in identifying device classifications and how can they be resolved? Are there any tools or resources available to assist in determining device classifications? \n <\/div> \n <div class=\"text-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Responsible person for determining device classifications <\/label> \n   <input type=\"text\" placeholder=\"Something will be typed here...\" disabled class=\"form-control\"> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"gather-all-relevant-documents-including-device-descriptions-labeling-and-safetysecurity-information\"> \n <h2>Gather all relevant documents including device descriptions, labeling, and safety\/security information<\/h2>\n <div class=\"text-content\">\n   For this task, you will gather all relevant documents related to the medical devices, including device descriptions, labeling, and safety\/security information. These documents provide critical information about the devices and ensure compliance with FDA regulations. By ensuring you have all the necessary documentation, you can effectively demonstrate the safety, effectiveness, and quality of your medical devices. What challenges might be encountered while gathering these documents and how can they be overcome? Are there any specific tools or resources available to assist in organizing and accessing these documents? \n <\/div> \n <div class=\"file-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Upload relevant documents <\/label> \n   <div class=\"file-container\"> <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-and-review-quality-management-system-qms\"> \n <h2>Prepare and review Quality Management System (QMS)<\/h2>\n <div class=\"text-content\">\n   In this task, you will prepare and review the Quality Management System (QMS) for your organization. The QMS is a crucial component for ensuring the safety and effectiveness of your medical devices. It outlines the processes, procedures, and responsibilities required to ensure compliance with FDA regulations. By thoroughly reviewing the QMS, you can identify any areas that require improvement and ensure that the system is effective in meeting regulatory requirements. What challenges might arise in preparing and reviewing the QMS, and how can they be addressed? Are there any specific tools or resources available to assist in developing and reviewing the QMS? \n <\/div> \n <div class=\"text-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Responsible person for preparing and reviewing QMS <\/label> \n   <input type=\"text\" placeholder=\"Something will be typed here...\" disabled class=\"form-control\"> \n  <\/div> \n <\/div> \n <div class=\"date-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Date of QMS review <\/label> \n   <div class=\"date-container\"> <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<\/section> \n<section id=\"ensure-qms-is-designed-as-per-fda-quality-system-regulation-qsr\"> \n <h2>Ensure QMS is designed as per FDA Quality System Regulation (QSR)<\/h2>\n <div class=\"text-content\">\n   For this task, you will ensure that the Quality Management System (QMS) is designed in accordance with FDA Quality System Regulation (QSR). The QSR provides guidelines and requirements for the design, development, and production of medical devices. By aligning your QMS with these regulations, you can ensure that your organization meets the necessary quality standards. What challenges might be encountered in aligning the QMS with FDA QSR, and how can they be overcome? Are there any specific tools or resources available to assist in ensuring QMS compliance with FDA QSR? \n <\/div> \n <div class=\"select-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> QMS compliance status <\/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      Compliant \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      Non-compliant \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n<\/section> \n<section id=\"approval-qms-design\"> \n <h2>Approval: QMS Design<\/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\"> <span class=\"title\">Prepare and review Quality Management System (QMS)<\/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\"> <span class=\"title\">Ensure QMS is designed as per FDA Quality System Regulation (QSR)<\/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=\"conduct-internal-audits-to-verify-qms-compliance\"> \n <h2>Conduct internal audits to verify QMS compliance<\/h2>\n <div class=\"text-content\">\n   In this task, you will conduct internal audits to verify the compliance of your Quality Management System (QMS) with FDA regulations. Internal audits help identify any non-compliance issues and areas for improvement. By regularly conducting internal audits, you can ensure that your QMS is effective and meets all regulatory requirements. Who is responsible for conducting internal audits? What challenges might be encountered during the audit process, and how can they be addressed? Are there any specific tools or resources available to assist in conducting internal audits? \n <\/div> \n <div class=\"text-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Responsible person for conducting internal audits <\/label> \n   <input type=\"text\" placeholder=\"Something will be typed here...\" disabled class=\"form-control\"> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"ensure-the-device-complies-with-fdas-device-regulations\"> \n <h2>Ensure the device complies with FDA's device regulations<\/h2>\n <div class=\"text-content\">\n   For this task, you will ensure that the medical devices used by your organization comply with FDA's device regulations. Compliance with these regulations is essential to demonstrate the safety, effectiveness, and quality of your devices. By verifying compliance, you can address any potential issues and ensure regulatory requirements are met. What challenges might arise in ensuring device compliance with FDA regulations, and how can they be overcome? Are there any specific tools or resources available to assist in verifying device compliance? \n <\/div> \n <div class=\"select-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Device compliance status <\/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      Compliant \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      Non-compliant \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n<\/section> \n<section id=\"prepare-risk-management-documents\"> \n <h2>Prepare risk management documents<\/h2>\n <div class=\"text-content\">\n   In this task, you will prepare risk management documents for your medical devices. Risk management is a critical aspect of ensuring the safety and effectiveness of medical devices. By identifying and addressing potential risks, you can mitigate the impact on patients and ensure compliance with FDA regulations. What challenges might be encountered in preparing risk management documents, and how can they be addressed? Are there any specific tools or resources available to assist in preparing risk management documents? \n <\/div> \n <div class=\"text-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Responsible person for preparing risk management documents <\/label> \n   <input type=\"text\" placeholder=\"Something will be typed here...\" disabled class=\"form-control\"> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"document-design-control-processes\"> \n <h2>Document design control processes<\/h2>\n <div class=\"text-content\">\n   For this task, you will document the design control processes for your medical devices. Design control is a crucial aspect of ensuring that devices meet the necessary requirements and are safe and effective. By documenting these processes, you can provide evidence of compliance with FDA regulations and facilitate effective communication within your organization. What challenges might be encountered in documenting design control processes, and how can they be addressed? Are there any specific tools or resources available to assist in documenting design control processes? \n <\/div> \n <div class=\"text-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Responsible person for documenting design control processes <\/label> \n   <input type=\"text\" placeholder=\"Something will be typed here...\" disabled class=\"form-control\"> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"check-and-confirm-vendor-qualifications\"> \n <h2>Check and confirm vendor qualifications<\/h2>\n <div class=\"text-content\">\n   In this task, you will check and confirm the qualifications of your vendors. Vendors play a crucial role in the supply chain for medical devices, and it is essential to ensure that they meet the necessary qualifications and standards. By verifying vendor qualifications, you can mitigate risks, ensure quality, and comply with FDA regulations. What challenges might arise in checking and confirming vendor qualifications, and how can they be addressed? Are there any specific tools or resources available to assist in evaluating vendor qualifications? \n <\/div> \n <div class=\"multi-select-content form-field-content\"> \n  <div class=\"form-group\"> <label> Vendor qualification checklist <\/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      Verify vendor certifications \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      Review vendor quality management system \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      Assess vendor track record \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      Evaluate vendor's compliance with FDA regulations \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      Check vendor references \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n<\/section> \n<section id=\"prepare-production-and-process-control-documents\"> \n <h2>Prepare production and process control documents<\/h2>\n <div class=\"text-content\">\n   For this task, you will prepare production and process control documents for your medical devices. These documents outline the procedures and controls necessary to ensure the consistent production and quality of devices. By preparing comprehensive production and process control documents, you can demonstrate compliance with FDA regulations and promote the safety and effectiveness of your devices. What challenges might be encountered in preparing these documents, and how can they be addressed? Are there any specific tools or resources available to assist in developing production and process control documents? \n <\/div> \n <div class=\"text-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Responsible person for preparing production and process control documents <\/label> \n   <input type=\"text\" placeholder=\"Something will be typed here...\" disabled class=\"form-control\"> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"organize-device-master-record\"> \n <h2>Organize device master record<\/h2>\n <div class=\"text-content\">\n   In this task, you will organize the device master record for your medical devices. The device master record is a comprehensive compilation of all documentation and information related to a specific device. By organizing the master record, you can easily access and provide the necessary information during an FDA audit or inspection. What challenges might arise in organizing the device master record, and how can they be addressed? Are there any specific tools or resources available to assist in organizing the master record? \n <\/div> \n <div class=\"text-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Responsible person for organizing device master record <\/label> \n   <input type=\"text\" placeholder=\"Something will be typed here...\" disabled class=\"form-control\"> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"assemble-device-history-record\"> \n <h2>Assemble device history record<\/h2>\n <div class=\"text-content\">\n   For this task, you will assemble the device history record for your medical devices. The device history record provides a detailed account of the production, testing, and inspection of each device. By assembling the device history record, you can demonstrate compliance with FDA regulations and ensure traceability and accountability throughout the device lifecycle. What challenges might be encountered in assembling the device history record, and how can they be addressed? Are there any specific tools or resources available to assist in assembling the record? \n <\/div> \n <div class=\"members-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Person responsible for assembling device history record <\/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<\/section> \n<section id=\"compile-complaints-and-recalls-log\"> \n <h2>Compile complaints and recalls log<\/h2>\n <div class=\"text-content\">\n   In this task, you will compile a log of complaints and recalls related to your medical devices. Keeping track of complaints and recalls is essential for continuous improvement and regulatory compliance. By compiling a comprehensive log, you can identify trends, address issues promptly, and implement corrective measures to prevent recurrence. What challenges might arise in compiling the complaints and recalls log, and how can they be addressed? Are there any specific tools or resources available to assist in managing the log? \n <\/div> \n <div class=\"file-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Upload complaints and recalls log <\/label> \n   <div class=\"file-container\"> <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=\"train-your-employees-on-the-audit-processes\"> \n <h2>Train your employees on the audit processes<\/h2>\n <div class=\"text-content\">\n   For this task, you will train your employees on the audit processes related to FDA regulations for medical devices. It is essential to ensure that your employees are familiar with the audit procedures and understand their roles and responsibilities in maintaining compliance. By providing adequate training, you can enhance awareness, competency, and confidence while minimizing the risk of non-compliance. What challenges might be encountered in training employees on the audit processes, and how can they be addressed? Are there any specific tools or resources available to assist in conducting the training? \n <\/div> \n <div class=\"text-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Responsible person for conducting employee training <\/label> \n   <input type=\"text\" placeholder=\"Something will be typed here...\" disabled class=\"form-control\"> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"review-premarket-approval-or-510k-submissions\"> \n <h2>Review pre-market approval or 510(k) submissions<\/h2>\n <div class=\"text-content\">\n   In this task, you will review pre-market approval or 510(k) submissions for your medical devices. These submissions are required by the FDA to demonstrate the safety and effectiveness of new devices or modifications to existing devices. By thoroughly reviewing the submissions, you can ensure compliance with FDA regulations and address any potential issues or concerns. What challenges might be encountered in reviewing pre-market approval or 510(k) submissions, and how can they be addressed? Are there any specific tools or resources available to assist in the review process? \n <\/div> \n <div class=\"select-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Submission review status <\/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      Completed \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      In progress \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      Not started \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n<\/section> \n<section id=\"approval-premarket-or-510k-submission\"> \n <h2>Approval: Pre-market or 510(k) 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\"> <span class=\"title\">Review pre-market approval or 510(k) submissions<\/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=\"ensure-corrective-and-preventive-action-capa-processes-are-in-place\"> \n <h2>Ensure Corrective and Preventive Action (CAPA) processes are in place<\/h2>\n <div class=\"text-content\">\n   For this task, you will ensure that Corrective and Preventive Action (CAPA) processes are in place for your organization. CAPA processes help identify and address non-compliance issues, prevent recurrence, and drive continuous improvement. By establishing robust CAPA processes, you can ensure compliance with FDA regulations and enhance the overall quality and safety of your medical devices. What challenges might be encountered in implementing CAPA processes, and how can they be addressed? Are there any specific tools or resources available to assist in establishing and managing CAPA processes? \n <\/div> \n <div class=\"text-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Responsible person for implementing CAPA processes <\/label> \n   <input type=\"text\" placeholder=\"Something will be typed here...\" disabled class=\"form-control\"> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"prepare-for-the-fda-site-inspection\"> \n <h2>Prepare for the FDA site inspection<\/h2>\n <div class=\"text-content\">\n   This task involves preparing for the FDA site inspection of your organization's facilities and processes related to medical devices. The FDA site inspection is a comprehensive evaluation of your organization's compliance with FDA regulations. The task aims to ensure that all necessary preparations are made to facilitate a successful FDA site inspection. Have you prepared for the FDA site inspection? What preparations have been made? \n <\/div> \n <div class=\"multi-choice-content form-field-content\"> \n  <div class=\"form-group\"> <label> Preparation Status <\/label> <select disabled class=\"form-control\"> <option value=\"\">Multiple options can be selected from this list<\/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      Not Prepared \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      Prepared \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Preparations for FDA Site Inspection <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"approval-final-checklist-before-fda-audit\"> \n <h2>Approval: Final checklist before FDA Audit<\/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\"> <span class=\"title\">Prepare risk management documents<\/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\"> <span class=\"title\">Document design control processes<\/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\"> <span class=\"title\">Check and confirm vendor qualifications<\/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\"> <span class=\"title\">Prepare production and process control documents<\/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\"> <span class=\"title\">Organize device master record<\/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\"> <span class=\"title\">Assemble device history record<\/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\"> <span class=\"title\">Compile complaints and recalls log<\/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\"> <span class=\"title\">Train your employees on the audit processes<\/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\"> <span class=\"title\">Ensure Corrective and Preventive Action (CAPA) processes are in place<\/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\"> <span class=\"title\">Prepare for the FDA site inspection<\/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","protected":false},"excerpt":{"rendered":"<p>Identify the medical devices and their classifications In this task, you will identify the medical devices used by your organization and determine their classifications. This is crucial as different device classifications have varying regulatory requirements and guidelines. By accurately identifying the devices and their classifications, you can ensure proper adherence to the applicable regulations and [&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\udd0d","cover_icon_url":"","tasks_count":"20","template_description":"","template_id":"l4_K7tY7yzDcgVvM87ZJ2g","task_0":"Identify the medical devices and their classifications","task_slug_0":"identify-the-medical-devices-and-their-classifications","task_1":"Gather all relevant documents including device descriptions, labeling, and safety\/security information","task_slug_1":"gather-all-relevant-documents-including-device-descriptions-labeling-and-safetysecurity-information","task_2":"Prepare and review Quality Management System 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