Effective Validation & Verification (V&V) processes ensure that the design intent meets client and regulatory requirements. The FDA will routinely request that OEMs provide all product documentation (including records, designs, drawings, approved Production Part Approval Process (PPAP) results, etc.) within 24 hours.
This regulatory burden makes it critical to have all elements of product development well-documented, organized, and up-to-date throughout the entire process.
See Winning Project Management Practices for Medical Device Development
Ensuring that the overall design process enhances and supports the V&V phase of the project is crucial to success and eliminating delays. While not an exhaustive list, the following PPAP components are particularly important:
- Design Failure Modes and Effects Analysis (DFMEA)
- Process Failure Modes and Effect Analysis (PFMEA)
- Design For Manufacturability (DFM)
- IEC 60601 Third Edition Compliance Plan
All of these components collaborate to form a robust quality plan and lay the groundwork for a meaningful validation to both the client requirements and all industry regulations.
Involving all elements of the product development process – Industrial Design, Design Engineering, Supply Chain Management, Quality Assurance, and Manufacturing – enables a well-coordinated plan to be developed to conduct predictive testing, build functional mock-ups, and perform testing early in the process in accordance with the Product Requirements Specification. Not only does early involvement ensure continuity and compliance throughout, it also eliminates costly product changes downstream.