In response to the experience seen in industry, I have similar input as hruship101 and srg36. Working for a global SMBG company, validation and verification (V&V) is understood to be our leading factor in producing products of high quality. Accuracy, durability, reliability, and consistency are very critical aspects in providing persons with Diabetes their blood glucose readings. Since the majority of our products are Class II medical devices, our V&V process follows a specific product-based FDA guidance. To determine the V&V activities that will be conducted for each of our products, whether new or updated, there must be transparent and consistent collaboration between the Quality, R&D, Operations, and Regulatory teams. The baseline is established from the requirements for CE mark (ISO standards), Health Canada, and FDA 510k submissions. These requirements mostly focus around the FDA guidance, since the U.S. is the most stringent. Additional reliability and environmental V&V tests are included, ensuring good practice and that quality expectations are being exceeded. Each company is unique in their own methods. This SMBG company created their own product guidelines, listing requirements at each stage or product development. For a better understanding of our V&V process: testing pilot run prototypes (could be multiple versions depending on the development of the product; usability, software, reliability, linearity, virucidal, aging, biocompatibility, sterility, etc.), testing installation, operation, and production assembly (IQ, OQ, and PQ with sterility), testing pre-production product samples (confirmation of the same tests done for prototypes, but now for regulatory submissions), packaging/labeling tests, then final tests in mass-production product samples. In trying to state the importance of V&V testing, this company has been performing V&V tests for blood glucose systems for over 30 years, and they are still continuously thinking of ways to modify or have additional tests to improve the quality of their product.