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We interviewed Educo Life Sciences trainer Richard Young to discuss product and process validation in medical devices. During the interview we discuss the following:
-What is product and process validation and why do we have to do it?
-Is it difficult and what are the common mistakes made?
-That planning is critical for validation
-You may need to consider and plan for some big product validation testing such as Biocompatibility testing and EMC testing.
-Process validation is also a big area of planning as manufacturing facilities may be disrupted whilst validating.
-Make sure your documents are well written and they link to the expected performance of the product.
-Does product complexity impact process and product validation?
#medicaldevices #educolifesciences #validation
