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FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Devices
The FDA recently released a 45-page draft guidance detailing the use of chemical analysis in biocompatibility assessments for medical devices.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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MDR
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5.11.2020
Preparing your QMS for EU MDR
MDR
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5.11.2020
Documentation impacted by EU MDR
5.11.2020
