MedCrypt
MedCrypt provides a regulatory cybersecurity platform that helps medical device manufacturers achieve first-time FDA submission approval by scoring readiness against eSTAR sections and running automated audits that analyze threat models, risk assessments, and SBOMs as one body of evidence. The platform returns reviewer-style findings ranked Critical, Major, or Minor with cited requirements, and former FDA reviewers validate packages before filing with a guaranteed 100% approval rate.
- Regulatory & Compliance Technology
- Cybersecurity
- Software Only
Funding
Funding not disclosed
Founders
Founder details are not available yet.
Product
Problem
Medical device cybersecurity submissions to the FDA are complex and frequently rejected due to missing evidence or incomplete documentation. Companies often discover gaps only after filing, resulting in costly resubmissions, delayed launches, and extended regulatory timelines.
Solution
MedCrypt provides a regulatory cybersecurity platform that scores submission readiness by eSTAR section, running automated audits that read the threat model, risk assessment, and SBOM as one body of evidence. The platform returns reviewer-style findings ranked Critical, Major, or Minor, each with the specific requirement cited, and tracks every finding to closure or dismissal with a reason. Former FDA reviewers validate the package before filing, with a guaranteed 100% FDA approval rate. The same platform view becomes a defensible record of cybersecurity compliance, and the annual Section 524B re-run becomes a re-scan rather than a rebuild.
Target Audience
Primary customers are medical device manufacturers preparing FDA cybersecurity submissions, regulatory affairs teams, and quality assurance professionals who need to close evidence gaps and achieve first-time approval. The platform also serves teams managing postmarket cybersecurity obligations including SBOM monitoring, incident response, and regulatory change management.
Features
- eSTAR-based readiness scoring that classifies each section as fulfilled, partial, or not fulfilled
- Automated Regulatory Audit that analyzes threat models, risk assessments, and SBOMs as a unified evidence body
- Findings ranked Critical, Major, or Minor with cited regulatory requirements attached
- Open-finding tracking until closure or dismissal with documented reasoning
- Pre-filing review and triage by former FDA reviewers
- Postmarket capabilities including SBOM validation and monitoring, incident response tabletop exercises, vulnerability and patch strategy, and legacy device security assessments
- Support for non-US submissions including Canadian licensing and EU CRA compliance with mandatory vulnerability reporting starting September 11, 2026