Specialized support for Software as a Medical Device throughout classification, development, and validation phases.
- SaMD classification & development planning
- Software architecture & requirements traceability
- Cybersecurity & usability documentation
- Verification & validation (V&V) support
SaMD Lifecycle
Our Approach
Classification & Planning
Determine your SaMD classification under MDR, FDA, and international frameworks to set the right regulatory path from day one.
Software Development Documentation
Prepare architecture documentation, software requirements, and traceability matrices aligned with IEC 62304 and FDA expectations.
Cybersecurity & Usability
Address cybersecurity risk documentation and usability engineering files as required by current regulatory guidance.
Verification & Validation
Support V&V planning, execution, and reporting to demonstrate software safety and effectiveness for regulatory submission.
Post-Market Maintenance
Manage software lifecycle updates, vigilance reporting, and ongoing compliance as your product evolves in the market.