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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Small Business Determination Requests Now Accepted Through CDRH Portal
The FDA recently released a significant update to its Center for Devices and Radiological Health (CDRH) Portal, allowing medical device companies to send…
FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Devices
The FDA recently released a 45-page draft guidance detailing the use of chemical analysis in biocompatibility assessments for medical devices.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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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
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15.02.2020