Ready, Set, Prep for the Four Types of FDA Inspections As a medical device manufacturer, Federal Drug Administration (FDA) inspections...
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True Quality Virtual Summit: Global Medical Device Regulatory Updates By Anne Holland CEO, QA Consulting, Inc. MedTech regulations are evolving….
Do you know how to handle complaints regarding your medical device? Medical device companies that market their devices in Europe…
Guest Author: Tasha Bond, Founder of Ikigai Medical Development and COO of Sana Health, Inc. Many medical device manufacturers relegate…
Author: Amber Hilfiger, Principal Consultant Navigate FDA Good Documentation Practices and Master the Art of Paper Trails Picture this: you're...
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Author: Jerry Sudduth, Regulatory Consultant The EU Medical Devices Regulation (MDR) Date of Application (DoA) takes effect today. Do you understand…
Guest Author: Ali Gallagher, J.D. Non-compliance with FDA regulations can not only delay your product getting in the hands of…
By QA Consulting, Inc. With the rising demand for connected medical devices, understanding your products’ potential vulnerabilities and the evolving…
