FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Devices
The FDA recently released a 45-page draft guidance detailing the use of chemical analysis in biocompatibility assessments for medical devices. This…
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Understanding How to Properly Evaluate Suppliers per FDA Requirements 21 CFR 820.50
Purchasing Controls and Supplier Evaluations are a critical component of quality management for medical device manufacturers, ensuring that materials,…
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We began as a small group of tech enthusiasts with a shared vision: to revolutionize the digital landscape. Over the years, we have grown into a full-fledged web design
