You can use Medcrypt to prepare, audit, and manage cybersecurity documentation for medical device regulatory submissions. The system assesses your device maturity across security design, supply chain tracking, verification testing, and postmarket surveillance. You can audit threat models, software bill of materials, and risk assessments directly against FDA eSTAR requirements before filing. It highlights specific gaps with severity ratings and regulatory citations, giving your engineering and regulatory teams a clear path to fix deficiencies and secure faster FDA premarket approval without unexpected delays.
What Medcrypt does
Pricing breakdown
Pricing model: Free tier, Paid
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