Invention Disclosures for Medical Devices (Summary)
AI Patent GeneratorWhat medical device teams should capture in invention disclosures, including safety, regulatory constraints, data provenance, and verification/validation.
For medical devices, include domain-specific details:
- Clinical context and intended use; applicable standards and regulatory class.
- Risk analysis (e.g., ISO 14971) and safety mechanisms.
- Data provenance, labeling, and traceability; PHI handling and compliance.
- Hardware-software interface specs, sensors/actuators, calibration.
- Verification and validation plan, bench tests, and clinical evaluation strategy.
- Post-market surveillance/monitoring design.