Medcrypt

Medcrypt

Solana Beach, California, United States

GRC & ComplianceIdentity & AccessApplication SecurityData Protection
Founded 2016Serves Enterprise, SMB
Profile last updated: May 6, 2026

About

Founded in 2016, Medcrypt is a cybersecurity company based in Solana Beach, United States working in grc & compliance, identity & access, application security +3 more.

Medcrypt is a medical device cybersecurity company founded in 2016 and led by former FDA reviewers and policy architects. It offers cybersecurity products and consulting services for medical device manufacturers, supporting FDA, EU MDR/IVDR and Health Canada submissions across the device lifecycle from pre-market to post-market. Its products include Helm, an SBOM and vulnerability management platform built for medical devices, and Guardian, a PKI and cryptography platform for device identity, authentication and encrypted communication, including legacy devices that cannot be modified. Services include threat modeling, encryption architecture reviews, penetration testing, FDA submission support, regulatory readiness assessments, SBOM management, post-market vulnerability management, incident response planning and cybersecurity training. The company works with manufacturers ranging from startups to large device makers and operates in the United States, European Union and Canada. Medcrypt also funds medical device security research with academic partners, including Tufts University and Kansas State University.

Location

Solana Beach, United States

Founded

2016

VAT number

PT877632797

Focus areas

medical device cybersecuritySBOMvulnerability managementPKIcryptographythreat modelingFDA complianceSection 524B

Languages

EN

Services & products

Security domains

GRC & ComplianceIdentity & AccessApplication SecurityData ProtectionPenetration TestingIncident Response

How they deliver

SoftwareProfessional ServicesConsultingTraining

Products

Helm

SBOM and vulnerability management platform

Manages software bill of materials and vulnerability lifecycle for medical devices, with AI-driven risk prioritization and FDA-ready reporting.

Guardian

PKI and cryptography platform

Provides device identity, certificate provisioning, authentication and encrypted communication for medical devices, including legacy devices.

Product Security Intelligence Platform

Product security posture assessment platform

Benchmarks medical device product security posture, quantifies financial risk of cybersecurity gaps and prioritizes remediation.

Customers

EnterpriseSMB

Industries served

Medical DevicesHealthcare

Compliance & partners

Compliance frameworks

FDA Section 524BFDA Premarket CybersecurityFDA Postmarket CybersecurityEU MDREU IVDRHealth Canada Medical Device CybersecurityISO 14971ISO 13485IEC 62304IEC 81001-5-1AAMI TIR57AAMI SW96UL 2900

Technology partners

RTI

Credentials & affiliations

Industry memberships

GSMA Device Security GroupMedISAO

People

Management & team (4)

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