Custom tools to simplify regulatory positioning
Am I building a medical device?
What does my device do? Who is it intended for? How does it work?
Not sure whether you are building a medical device or a wellness product? Take our Device Positioning Tool for a spin. See how you are likely to be classified, and get feedback on aspects that need some extra attention.
The Device Positioning Tool is free to use, currently in beta version. If you experience any bugs, please let us know as we continue to develop useful tools for the community.
QMS gap analysis (EU MDR, ISO13485)
A 188-point inspection of your QMS and technical file
A proprietary assessment tool that systematically evaluates your medical device company's readiness for CE marking under the EU MDR — covering your quality management system, technical file, clinical evidence, post-market surveillance, and regulatory obligations — and delivers a clear, actionable gap analysis report you can act on immediately.
