The first article in this series discussed the background and a few high-level observations of the FDA’s summaries of its medical device quality system inspections. This article digs into the details of the FY2020 observations. What were the top 10 most-cited issues, and what are the takeaways you can implement?
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By Bob Emmett and Luke Lorson,Carclo Technical Plastics
When subcontracting medical or optic injection-molded components, do you carefully evaluate your molder’s validation process? There is only one approach that is proven to keep your molded parts “in spec”: decoupled molding.
Class III medical devices have a unique set of requirements and package characteristics that need a comprehensive approach to selecting the right inspection methods. A variety of inspection methods exist for medical package inspection that require a thorough understanding to ensure quality.