Here is a list of the essential cybersecurity documentation and artifacts you will require for your FDA, TGA, and MDR submission:
- Cybersecurity Risk Management Plan
- Cybersecurity Risk Assessment and Analysis
- Threat Modeling Report
- Vulnerability Assessment and Penetration Testing Reports
- Software Bill of Materials (SBOM)
- Security Design Documentation
- Access Control Measures Documentation
- Data Integrity and Confidentiality Measures
- Encryption and Key Management Documentation
- Secure Software Development Lifecycle (SDLC) Documentation
- Incident Response Plan
- Postmarket Cybersecurity Plan
- Labeling and User Documentation (including cybersecurity instructions)
- Third-Party Components and Services Security Documentation
Let us know if you like our team to assist with this list.
