Which regulations and standards apply to your device?

A guided intake for medical-device quality and regulatory teams. Answer a short set of questions about your device and get a candidate list of US (FDA) and EU (MDR) regulations, standards and guidance — organised by lifecycle stage.

~10–15 minutesBranching questions — you only see what applies to your device.

Private by designRuns entirely in your browser. No product name required; nothing is sent or stored on a server.

Staged outputResults grouped into design & development, clinical, post-market and ongoing.

Before you start

Your role

Project name (optional — no product or brand name needed)

I will use this tool for my organisation's own internal assessment, consistent with the intended use above. I understand this is an informational reference tool — not a regulatory, legal or medical determination — and that I am solely responsible for confirming applicability.

No sign-up. No data leaves your device.

Informational reference tool · Verify against FDA, EUR-Lex, ISO, IEC, ASTM and USP · Not regulatory or legal advice