Most quality teams haven't updated their QMSR audit prep for it yet.
We map your QMS cybersecurity elements against the same evidence categories inspectors actually cite — so you walk in with the file already assembled, not scrambling the week before.
Across the first 100 QMSR inspections, this isn't a premarket checkbox anymore — it's a recurring postmarket obligation your QMS has to demonstrate every cycle.
Every claim in Medcrypt's platform carries a visible status — mapped to ISO 13485, ISO 9001, IEC 62304, and TIR57. That's the difference between believing you're compliant and showing exactly where it comes from.
An inspector doesn't take your word for it — they want the evidence trail. See where your QMS stands against the categories inspectors actually cite.
Section 524B(b)(2) made postmarket cybersecurity a standing mandate, not a one-time gate you clear and forget.
Annual reassessment should be a re-scan against what's changed, not a rebuild from a blank page.
Yearly internal audits and postmarket surveillance, without the internal resource drain.
Keeps your software supply chain visible and your postmarket obligations met.
Compliant QMS records built in connected templates, so evidence is generated, not assembled by hand.
Alerts when guidance shifts, mapped to the devices it affects.
Check your readiness for free, or talk through your QMS with an expert.
