Medcrypt

See what an FDA reviewer would catch.

Your submission is going to be reviewed against FDA's requirements line by line. Run that review first, against the requirements a reviewer actually applies, and fix what it finds on your own schedule before the review clock starts.

Scan your submission package

Features

Most tools check your package against the regulation. We check it against how the regulation is enforced.

The actual gap, against the actual rule

Findings are phrased the way a reviewer phrases them, and each one cites the requirement it maps to and the evidence behind it. No vague “improve your documentation”, and where the support for a finding is not there, the report says so.

Graded against how the rule is enforced

The checks reflect what FDA is actually catching, rejecting, and requiring, not just what the written guidance says. That is the difference between checking your package against the regulation and checking it against the way the regulation is applied.

One connected package

The scan reads your threat model, risk assessment, and SBOM as one body of evidence, the same way a reviewer does. Gaps between documents surface, not just gaps within them.

How we work with your team

Three steps, and the last one is a conversation.

The scan does the comparing. What makes a findings report useful is the part after it, when someone who has run these reviews tells you which findings would actually have held your submission.

  1. Bring the package you already have.

    Upload your submission documents or pull them from the collections you already keep. There is no reformatting to do first and no new template to author. Your threat model, risk assessment, and SBOM go in as they are.

    Documents

    Source documentStatus
    ArchitectureParsed
    InterfacesParsed
    Data flowsReading
    Extracting assets and data-flow diagram

  2. Every gap, filed where a reviewer would look for it.

    Your design and documentation are compared against the requirements a reviewer actually applies, and each gap is filed into the eSTAR section your submission will move through. Findings come back ranked by severity, so the ones that could genuinely hold your submission surface first instead of sitting in a queue beside the wording fixes.

    Findings

    FindingCitesSeverity
    3Critical
    5Major
    7Major
    9Minor
    Checking against FDA premarket requirements

  3. A person decides what is worth your time.

    Former FDA reviewers work through the findings with you. They separate the real risks from the noise, so a long report becomes a short list, and they help you shape the response you will actually file.

    Findings review

    CriticalRemediation
    MajorRemediation
    MajorIn review
    MinorNot a gap
    Triaged with former FDA reviewers

What you get

What lands in your hands.

A reviewer-style findings report

The gaps a reviewer would raise, each ranked Critical, Major, or Minor and written the way a deficiency is written, with the requirement it cites attached.

Readiness by eSTAR section

Where each part of your submission stands against the structure it will be reviewed in, so you can see which sections are ready to file and which still owe evidence.

Gap tracking and remediation

Each finding stays open until it is closed or dismissed with a reason, so a package that has been worked through can be told apart from one that has only been scanned.

Traceable evidence, end to end

Every finding shows the evidence behind it, verified against your documents or flagged plainly when the support is missing, so you and your regulators can audit why the platform said what it said. Run the same scan on every device, not just the one with a deadline.

Know where you are in 1 hour.

Run the free check or talk to a human. Either way, you’ll get a clearer view of readiness without a paywall or lengthy sales call.

Check readiness