Medical devices

Medical device compliance software that enforces execution by design

Q: How does Process Street help with medical device compliance?

We turn your SOPs, QMS requirements, and regulatory procedures into enforceable workflows that are audit-ready by default.

Q: Can I use Process Street to manage CAPA, design controls, and change management?

Yes. You can build structured workflows for each process and track every decision, action, and review.

Q: Is Process Street secure for regulated data and IP?

Absolutely. We're SOC 2 Type II and ISO 27001 certified. All data is encrypted, access-controlled, and never used for AI training.

Q: Does this support ISO 13485 and FDA requirements?

Yes. Teams use Process Street to support compliance with ISO 13485, FDA CFR Part 11, GxP, and more.

Q: Can I automate training and policy acknowledgment workflows?

Yes. You can assign training tasks, track completions, and manage recertifications with zero manual follow-up.

Q: Is Process Street flexible across product teams and sites?

Yes. It's fully no-code, so quality and regulatory teams can manage and adapt workflows for every product, team, or location.

Process Street helps medical device teams automate QMS workflows, enforce regulatory SOPs, and stay audit-ready for FDA, ISO 13485, and GxP, without manual oversight.

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Trusted by more than 3000 companies

Compliant teamwork, one platform

From design controls and document approvals to CAPA and internal audits, Process Street gives medical device manufacturers a single system to manage, automate, and prove every step of the compliance lifecycle.

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Design control & document reviews

Route design documents for approval, track versions, and link every change to traceable workflows.

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ISO 13485 & QMS enforcement

Turn your QMS into an execution system. Automate procedures, assign tasks, and log every action.

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SOP execution & acknowledgment tracking

Ensure critical procedures are followed with task assignments, tracked completions, and digital sign-offs.

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CAPA & nonconformance management

Capture deviations, assign corrective actions, and ensure timely resolution with full traceability.

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Meet Cora,
your AI compliance agent

AI-powered compliance, policy, and workflow automation, always up-to-date, always audit-ready.

Creates policies Instantly generate ISO, SOC 2, and HIPAA-compliant policies.
Builds workflows Transform static documents into actionable, trackable workflows.
Monitors regulations Stay ahead of regulatory changes with real-time updates.
Audits automatically Cora flags compliance gaps and keeps your documents aligned.

Compliance isn’t static anymore.

With Cora, your policies, procedures, and workflows stay living, dynamic, and audit-ready automatically.

Discover how Cora works

Training & certification workflows

Assign, track, and document employee training for regulated roles, automatically.

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Internal audits & FDA inspection prep

Run internal audits and inspection readiness workflows that document every step with zero extra admin.

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Supplier qualification & monitoring

Standardize onboarding, track compliance, and document ongoing supplier assessments.

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Change control & validation

Ensure every change follows a validated path with approval routing, impact assessment, and evidence tracking.

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Frequently asked questions

Can't find the answer you need? Contact our support team.

How does Process Street help with medical device compliance?

Can I use Process Street to manage CAPA, design controls, and change management?

Is Process Street secure for regulated data and IP?

Does this support ISO 13485 and FDA requirements?

Can I automate training and policy acknowledgment workflows?

Is Process Street flexible across product teams and sites?

Unwavering security & compliance

Your data's security and privacy are our top priorities. We adhere to the strictest data protection and compliance standards, allowing you to concentrate on delivering unmatched client value.

Data protection & security

ISO27001 compliance

Process Street is ISO 27001 certified, confirming compliance with global standards and a strong commitment to protecting customer data through audited, continuously monitored security controls.

Data protection & security

SOC 2 Type II compliance

Process Street has passed a SOC 2 Type II audit, confirming that it meets various criteria for safeguarding customer data. An independent external auditor has verified the effectiveness of the controls implemented by Process Street.

Healthcare information privacy

HIPAA compliance

HIPAA, a federal law, safeguards patient health information. Process Street's robust security measures include the option for a Business Associate Agreement upon request, ensuring HIPAA compliance.

Data protection & security

AWS CIS compliance

The CIS AWS Foundations Benchmark provides security best practices for AWS environments. Process Street's compliance ensures a secure cloud infrastructure by following established guidelines for configuration and monitoring.

EU Data protection & privacy

GDPR compliance

The General Data Protection Regulation (GDPR) is an EU law designed to protect the privacy of individuals and businesses in the EU economic area. It establishes rules for how personal data is collected and handled. Read our GDPR statement

Data protection & privacy

CCPA compliance

The California Consumer Privacy Act (CCPA) gives California residents more control over their personal data, including rights to access, delete, and opt out of data sales. Process Street ensures compliance through transparent practices.

Security & privacy

Artificial intelligence

Your data is never used to train AI models. Any data read or created by a workflow is exclusive to that particular workflow instance and cannot be accessed otherwise, even from within the same organization.

Data sovereignty & infrastructure

Data residency & private cloud

Choose where your data is stored with support for US, UK, Canada, EU, and UAE regions. Customers can also opt for private cloud deployment in their own VPC for maximum control and security.

Backed by happy clients

With Process Street we've been able to bring documentation to life… allowing us to adapt processes quickly, improve governance and achieve consistent results