Author: Anne Holland, CEO and Founder The countdown is on for the Quality Management System Regulation (QMSR) transition. While at…
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We’d like to welcome QA Consulting’s new Director of Quality and Regulatory, Laura Lakemeyer! We’re excited to announce that…
Author: Anne Holland, CEO and Founder Navigating the New Quality Management System Regulation: Insights from Our Latest White Paper We…
Author: Ella Wheeler, Director of Operations and Senior Quality Engineering Consultant Continuous Improvement (CI) is no longer a slow and…
Author: Emerance Gummels, Principal Software and Regulatory Consultant Cybersecurity for medical devices is crucial to protect patient data and device…
Author: Ella Wheeler, Director of Operations and Senior Quality Engineering Consultant As medical device manufacturers strive to bring innovative products…
Author: Sallie McLaughlin, Principal Microbiology Consultant Understanding and Overcoming Sterility Test Failures in Medical Device Radiation Dose Audits Paying close…
Post-Market Compliance Strategy Expertise Once your medical device goes to market, it doesn’t mean you’re done with compliance. Medical device...
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EU MDR Overview The European Union Medical Device Regulation governs the safety, quality, and performance standards for medical devices marketed...
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Quality Knowledge. Quality Systems. Quality Devices. Medical device quality system training is continuous and essential for getting on the fastest...
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