Medical Device Software and System V&V
Challenge
Client needed additional resources for software and system verification and validation (V&V) on an innovative new wireless medical device. Client needed help to develop V&V plans, conduct software risk analysis, develop Software Requirements Specifications and conduct software and system V&V.
Actions
Worked with client to establish document structure for the project, then supported the creation, update and refinement of software documentation. Specifically:
- Developed Software Requirements Specifications from product requirements.
- Assisted development of Software Risk Analysis.
- Created software verification protocols.
Worked with client to establish document structure for the project, then supported the creation, update and refinement of product documentation. Specifically:
- Developed and updated product Design Verification Plan.
- Updated System Architecture documentation.
- Created and updated Hardware Design Specifications.
Future Actions
Work with client to execute software verification. Specifically:
- Execute software verification protocols.
- Write software verification reports.
Worked with client to establish document structure for the project, then supported the creation, update and refinement of product documentation. Specifically:
- Write product Design Verification protocols.
- Organize and oversee product testing at external test labs for environment, electrical safety and EMC.
Result
Client completing product design, verification and validation to be able to submit to Regulatory approvals and move into manufacturing transfer.