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How should code editors like VS Code be validated in SaMD development?

Anonymous · Published February 08, 2026 · 1 comment
For companies developing Software as a Medical Device (SaMD), is it necessary to validate code editors such as Visual Studio Code as part of the QMS software tool validation? How should their use be justified or documented?

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Anonymous 4 months ago
If the code editor does not impact code quality or compliance with coding standards, extensive validation may not be required.
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6 Answers

Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
The more important part is usually your supplier evaluation process. Many QMS setups I've worked with didn't require purchase orders for service suppliers, and this was never an issue during audits. As long as you have contracts or agreements that clearly define your purchasing requirements and you evaluate your suppliers, you should be fine. Just make sure your documentation is consistent and reflects your actual process.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
In practice, most companies only sign a new Declaration of Conformity (DoC) when there are significant changes—like updates to the intended use, new UDI-DI, or changes affecting the compliance summary in the DoC. Frequent updates to technical documentation, such as instructions for use, don't always require a new DoC. Linking the DoC to major software versions or major changes is a common approach. You can also reference deliverables in the DoC without specifying versions, and keep a separate list of current document versions as needed.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
We follow a risk-based approach. First, assess which tools have the most impact on the quality of your output or compliance. You don't need to validate every tool—focus on the highest-risk ones. Higher risk might also mean more frequent re-validation. For things like document management systems, yes, validate them, but for generic communication tools or code editors, it's usually not needed. Always document your reasoning and re-assess if your usage changes.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
Yes, you can use non-US clinical data for a 510(k) as long as you can justify that your study population and clinical environment are representative of US use. The FDA has specific guidance stating that data from outside the US may be acceptable provided it is relevant to the US population and intended use environment. Make sure to reference their guidance and be ready to explain your rationale.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
Usually, employees are assigned procedures to read based on their role, and completion is tracked in a system or spreadsheet. Most systems require employees to acknowledge they have read and understood the procedure, and managers monitor compliance. Some companies also use onboarding plans to define specific training per role, and more interactive or in-depth training for complex procedures. Traceability and timely updates are important, especially when procedures change.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
We argue that since code editors like VS Code are industry standard and don't affect compliance with our coding standards (those are checked separately), they don't need to be validated as part of the QMS. The quality of the software doesn't depend on the choice of editor, so we just document our rationale for not validating them.

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