Design Qualification including Method Development; verification and validation
ISO13485:2016, chapter 7.3 — specifically 7.3.6 (Design and development verification) and specifically 7.3.7 (Design and development validation) — directs how to assess design qualification of medical devices.
Firstly, the technical specifications, traceability, and vendor acceptance are carefully reviewed to ensure a perfect match. This is done by meticulous review of the User Requirement Specifications (URS).
Secondly, detailed design specifications, including product drawings, undergo an audit. Any deviations are documented and shared with both the vendor and the company. This action is imperative as you need to make an audit of the detailed design specifications. This is mainly due to the process of tracing and also the drawings of the products. At this stage, deviations are recorded and are submitted to the vendor and the documentation for the company as well.
Thirdly, detailed design specifications are evaluated based on deviation reports, and a summary of results is created. Corrective actions are then addressed during site acceptance tests or product commissioning.
Employing the INSAKATO approach, i.e. looking from the fundaments of physics and statistics, imply a reasonable and pragmatic approach to solve your challenge.
Subsequently, a Pareto analysis of your factors influencing your risk, is made, where the outcome is to set up an appropriate Design of Experiment (DoE). This requires a profound understanding of statistics.
By the use of a design validation protocol, it is possible to determine if the item will deliver its full functionality based on the URS. It should also conform to the requirements of the Validation Master Plan.
