Benchmark your cybersecurity documentation against how the FDA actually reviews it — before you file, not after a rejection.
We help you build a submission that clears FDA review the first time — every section below is scored and backed by evidence before you file, not patched together after a deficiency letter.
Medcrypt's own 2026 top-deficiency analysis points to the same recurring, fixable gaps.
Unresolved findings with no documented risk justification.
Filtered before submission. FDA cross-references public vulnerability databases — a gap questions your whole framework.
Treated as optional guidance when they're a mandatory checklist.
Insufficient secure-configuration guidance and connectivity disclosure.
Review teams are working through more submissions with less slack in the schedule. A round of deficiency findings doesn't cost the six months it used to — it costs more, because the queue behind you hasn't gotten any shorter.
Filing clean the first time is worth more than it was a year ago.
Score your submission in about thirty minutes and see which eSTAR sections still owe evidence — the same categories FDA actually reviews against.
Former FDA reviewers and standards authors are behind the readiness scoring and the expert review option — that's not a marketing claim, it's who wrote the workflow.
Scan your submission package against requirements before you file.
Structured, deficiency-by-deficiency support with priority reviewer access.
Threat models and submission docs, drafted from what you already have.
Search FDA guidance and deficiency letters in plain language.
Check your readiness for free, or talk through your submission with a former FDA reviewer.
