Disclaimer

Last updated: March 2026

Not Legal or Regulatory Advice

This platform provides templates and collaborative tools for medical device regulatory professionals. The content available on Open Medical Device Guidance is not official regulatory guidance and should not be used as a substitute for professional regulatory advice. Always consult qualified regulatory professionals and legal counsel before making decisions based on any documents found on this platform.

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Open Medical Device Guidance creates original, community-written content through collective professional experience. Users must never copy or reproduce copyrighted material, including but not limited to published standards, official regulatory documents, or proprietary guidance from any standards body or regulatory authority. Violations may result in content removal and account suspension.

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Open Medical Device Guidance is an independent community project. It is not affiliated with, endorsed by, or associated with any national or international standards organization, regulatory authority, or government agency. All trademarks and trade names belong to their respective owners.

Community Content

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Intellectual Property

Users retain ownership of the original documents they create on this platform. Guidance documents published to the community are shared under open collaboration terms, meaning other users may view, create their own versions, and suggest improvements. Publishing a guidance does not transfer ownership, but it does grant the community the right to use it as a collaborative template. Users must ensure they have the right to publish any content they contribute.

Changes to These Terms

We reserve the right to modify these terms at any time. Changes will be reflected by an updated “Last updated” date on this page. Continued use of the platform after changes are posted constitutes acceptance of the revised terms.