Repeatedly accurate quality. 11. November 2021 If you want to ensure the highest possible product quality throughout the entire product cycle, you should have a development and manufacturing partner at your side with the necessary expertise in process validation. The ultimate aim of every contract manufacturer is to manufacture a product that is free of defects. In medical technology, however, the goal goes far beyond that: You must guaranteethat the product meets strict regulatory requirements and that the manufacturing processes were safely developed to ensure reliable performance throughout the entire lifecycle. „Therelevant regulations, whether ISO 13485, 21 CFR Part 820 or the EU Regulation on medical devices, are basically the same for everyone. Yet the customer‘s specifications often vary significantly. This is why WILD makes sure to guarantee quality as early as possible“, NPI Quality Engineer Markus Lippe explains. A currentdevelopment project for a surgical instrument stand demonstrates the advantages this can bring. „We identify details at an early stage during risk analysis, which we can eliminate without great effort, so they no longer cause any difficulties once we go into serial production.“ However, it is not rare to have customers approach WILD already during ongoing serial production. Recently WILD digitised the test method for a device used in the measurement of vital functions according to the customer‘s requirements and in compliance with the regulatory provisions. „This allowed us to rule out another source of errors and achieve a genuine efficiency gain“, Lippe stresses. PROCESS VALIDATION ALSO FOR OPTICS AND INDUSTRIAL PROJECTSFor industrial and optical technology companies, process validation is also increasingly moving towards centre stage. “For them, it is equally critical that WILD manufactures 100% according to specification. Therefore, we are increasingly resorting to initial sampling including documentation to obtain the necessary evidence with regard to dimensional accuracy, material composition, surface quality and much more.” At the end of the day, both quality and documentation must be up to standard. This is only possible through proactive quality planning and professional process validation, plus ongoing process reviews. The underlying condition for any validation is a risk analysis to determine the scope of validation. The installation qualification verifies that the facilities, machinery and equipment correspond to the manufacturer and process descriptions, and that they were correctly installed. Operation qualification ensures that the system is working in accordance withthe specifications. During the subsequent performance qualification, WILD furnishes proof that the process functions in a stable manner within the predetermined limits. The same applies to any modifications to the product. Where the customer carries out such modifications,WILD performs a re-evaluation.