Embedded Cybersecurity

Security Plan

Commitment to both pre and post market cybersecurity activities.

Risk Management

Threat modeling of assets and processes. Security architecture views. 

Supply Chain

Human and machine readable Software Bill Of Materials (SBOM). SBOM support report. Vendor assessments.

Online Training

A self paced video training with certification for medical device developers (for more details and sign up here). 

Security Controls

Authentication, authorization, cryptography, integrity, confidentiality, event detection, resiliency, & update. 

Testing

Fuzz testing, malformed inputs, attack surface analysis, penetration testing, vulnerability scanning, software content analysis, static analysis.

Labeling

Content to be added to the Instructions For Use (IFU) to address all 14 areas of transparency to the end user as required by the FDA.

Governance

Drafting corporate policy and procedures to comply with FDA, US Federal Government, and other international requirements (including EU's MDR).  

Postmarket Activities 

Fulfillment and periodic security upgrades to off the shelf (OTS) components 

Ongoing surveillance: subscription service to assure your device remains secure and compliant with FDA postmarket requirements.

This service includes (as required by FDA): Periodic reperformance of cybersecurity tests &  SBOM monitoring

Medical device incident response support team: assisting you in the event of adverse situations