Ready, Set, Prep for the Four Types of FDA Inspections As a medical device manufacturer, Federal Drug Administration (FDA) inspections...
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ISO 13485 Requirements and Audits: “What’s the Best Way of Doing This?” Align with the Latest Version of ISO 13485...
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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…
Do you know how to handle complaints regarding your medical device? Medical device companies that market their devices in Europe…
Author: Anne Holland, CEO and Founder As we move into 2022, we decided to take a step back and look…
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Author: Silas Minnick, Senior Quality Engineering Consultant On September 29, 2021, the FDA issued a draft guidance regarding a new…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 Verification and validation are crucial aspects of a medical device’s development. They work together…
Author: Sallie McLaughlin, Senior Microbiology Consultant EN 17141:2020 Cleanrooms and associated controlled environments – Biocontamination control, introduced in August of…
