Posted on Feb 14, 2019 by Software Specialists
- Execute requirement analysis, V&V planning, V&V protocol and V&V report writing.
- Maintain, validate and release Test Reports for design changes, ideally in FDA regulated business.
- Firm understanding of product/design Verification and Validation, and Software Validation, requirements and practices.
- Familiarity with and ability to understand Medical Device Product Safety Standards (IEC 60601-1, et. al) and regulations (FDA CFR 820, EU MDD).
- Guide and participate in tracking of issues, including problem identification, testing, solving and verification/validation.