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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 should we do it?
-Is it difficult and what are the common mistakes?
-That planning is crucial for validation
– You may need to consider and plan for some major product validation testing, such as biocompatibility testing and EMC testing.
-Process validation is also a large part of planning because production facilities can be disrupted during validation.
-Make sure your documents are well written and match the expected performance of the product.
-Does product complexity affect process and product validation?
#medicaldevices #educolifesciences #validation
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