A roadmap defining all steps and responsibilities is prepared for the transformation of the medical device design, which is at the idea stage, into a prototype and the preparation of the necessary regulatory documentation.
- Design Verification Test Setup
- Worst Case Representative Test Article Selection
- Statistical Analysis for Sampling
- Design validation
- Design transfer
According to this plan, meetings are organized with the customer and solutions are developed. If requested, NioReg experts will provide the appropriate documentation for the intended market. For more detailed service information, please visit NioReg website.
