FDA Inspection Observations (483s) — Current Trends and Preventing Escalation Ideally, you will have tactics and strategies in place to...
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Team Member Spotlight: Ella Wheeler Quality culture. Continuous improvement. Lean and Six Sigma. At QA Consulting, our team members strive...
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Your Device Made It To Market, Now What? Post-Market Surveillance How reliable is your device in the real world? Medical...
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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…
