Author: Anne Holland, CEO and Founder Navigating the New Quality Management System Regulation: Insights from Our Latest White Paper We…
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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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Team Member Spotlight: Kathy Johnson Broad Expertise. Collaborative Culture. Individual and Tailored Approach. At QA Consulting, we work as an...
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Intro to MDSAP What is MDSAP? The Medical Device Single Audit Program (MDSAP) is a single regulatory audit of a...
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