Streamline FDA CybersecurityCompliance for Medical Devices

Meet FDA's 2025 cybersecurity requirements with confidence. Conformia automates documentation, tracks vulnerabilities, and ensures your medical devices are submission-ready.

90%
Faster Documentation
100%
FDA Compliance
24/7
AI-Powered Support

Why Medical Device Companies Choose Conformia

Reduce Compliance Time by 90%

Automated documentation and AI-powered analysis dramatically reduce manual work.

Stay Ahead of FDA Requirements

Always up-to-date with the latest FDA cybersecurity guidance and requirements.

Reduce Operational Overhead

Streamline workflows with centralized dashboards, automated risk assessments, and real-time alerts. Conformia minimizes manual coordination between IT, BioMed, and compliance teams — freeing resources for higher-value work and speeding up incident response.

Expert Support

Direct access to cybersecurity experts and regulatory compliance specialists.

Everything You Need for FDA Cybersecurity Compliance

From SBOM generation to threat modeling, we've got you covered with AI-powered tools

Automated SBOM Generation

Generate comprehensive Software Bill of Materials instantly with vulnerability tracking

Threat Modeling

AI-powered threat analysis with STRIDE methodology and mitigation strategies

FDA-Ready Documentation

Pre-formatted templates that meet all FDA cybersecurity documentation requirements

Version Control Integration

Seamless integration with GitHub, GitLab, and Bitbucket for continuous monitoring

Risk Assessment

Comprehensive risk scoring with automated vulnerability assessment and tracking

AI Assistant - Cybi

24/7 AI support for compliance questions and automated documentation generation

Enterprise-Grade Security Features

Built from the ground up with security in mind, Conformia protects your sensitive medical device data with industry-leading security measures

End-to-End Encryption

All data is encrypted at rest and in transit using AES-256 encryption. Your sensitive medical device information is protected with bank-level security.

  • 256-bit SSL/TLS encryption for all data transfers
  • Encrypted database with rotating encryption keys
  • Secure key management with AWS KMS

HIPAA & FDA Compliant

Our platform meets all healthcare regulatory requirements, ensuring your data handling practices comply with HIPAA and FDA guidelines.

  • HIPAA-compliant infrastructure and processes
  • FDA 21 CFR Part 11 electronic records compliance
  • Regular third-party security audits

Ready to Simplify Your FDA Compliance?

Join leading medical device manufacturers who trust Conformia for their cybersecurity documentation needs