Author: Sallie McLaughlin, Principal Microbiology Consultant Understanding and Overcoming Sterility Test Failures in Medical Device Radiation Dose Audits Paying close…
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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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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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