I think validation is the most important process in a design control. As a project manager you need to know what is validation mean and how you validate a product. You need to make sure the device you have created is working in the human body and achieved the required goals. Validation is not only the right thing to do, but also its required by the FDA.Also, Quality System Regulation 21 CFR Part 820 and ISO 13485:2012 requiring the manufacturer to perform tasks associated with IQ’s, OQ’s and PQ’s. According to FDA regulations states “You always need to validate if results of a process cannot be fully verified by subsequent inspection and test”.
Validation cost a lot, so be aware that not all the medical devices need to be validated. For example as Dr.Simon mentioned, tongue depressor no need to be validated. If every input in the design control is truly and fully verified, so Validation is not required. Finally, by implementing a successful validation process, medical device manufacturers can improve productivity, reduce recalls and consumer complaints and also reduce the burdensome process of investigations.