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How ready are you, really?
Seven short steps about your device and your quality system, scored against the 116-activity MDR/IVDR and ISO 13485 implementation this platform is built on. You get a readiness figure, a breakdown by phase and by quality system essential, and for every gap the specific activity that closes it — with the smallest version of it that is still compliant.
Only what applies to your device is counted, so the score is not a generic checklist. About five minutes. We ask for an email at the end, to show you the result and to keep the link working.
Which route are you on?
This is the first gate in the roadmap, and it decides which half of the corpus applies to you — clinical evaluation under MDR, performance evaluation under IVDR.
It decides one thing here: whether a notified body has to assess you at all. MDR class I and IVDR class A can self-certify.