MedCrypt

MedCrypt Security Intelligence (MSI) is a compliance platform for medical device manufacturers that covers the full regulatory journey: building premarket documentation, auditing it against FDA expectations, managing software supply chain vulnerabilities, and maintaining compliance after clearance. It combines software with advisory support from former FDA reviewers.

MSI includes an eSTAR readiness check, cybersecurity maturity assessment, FDA submission audit, gap assessment reports, and deficiency letter response support. It also offers guided threat modeling, cybersecurity risk assessment, a requirements workbench, regulatory intelligence search, and document generation. The platform integrates Helm for SBOM and continuous vulnerability monitoring, along with MedISAO membership. Postmarket monitoring and automated self-audits help teams stay current after approval.

MSI is packaged as a per-product-line annual subscription that includes expert advisory hours, with penetration testing and additional advisory services available as add-ons. A free readiness check is offered for evaluating documentation gaps. An Enterprise edition supports multiple product lines with portfolio-level dashboards, custom requirements, SSO/SAML, and self-hosted deployment options. Helm can also be purchased separately for SBOM and vulnerability management.