Author: Emerance Gummels, Principal Software and Regulatory Consultant Cybersecurity for medical devices is crucial to protect patient data and device…
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True Quality Virtual Summit: Global Medical Device Regulatory Updates By Anne Holland CEO, QA Consulting, Inc. MedTech regulations are evolving….
Have you ever been in an FDA inspection? Are you prepared if your medical device company is inspected by the…
Author: Amber Hilfiger, Director of Operations and Principal Quality Engineering Consultant No one wants an FDA investigator to find an…
Author: Silas Minnick, Senior Quality Engineering Consultant On September 29, 2021, the FDA issued a draft guidance regarding a new…
Author: Anne Holland, CEO and Founder When medical device companies are looking to purchase supplies or services, it’s a no-brainer…
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…
