Category Archives: Regulatory Affairs

What to Look for in a Medical Device Quality and Regulatory Compliance Consulting Partner: The Definitive Checklist

Author: Anne Holland, CEO and Founder You know the drill. You’re tasked with identifying and selecting a medical device quality and regulatory compliance consulting partner. Once the initial panic wears off, you start searching for companies that can help navigate the complex environment. Throughout the process, you long for a roadmap or checklist of the…
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Navigating the FDA Emergency Use Authorization (EUA) Requirements for PPE and Medical Devices

FDA RESPONSIVE TO THE PUBLIC HEALTH RISK ASSOCIATED WITH COVID-19 Author: Anne Holland, CEO and Founder One does not generally think of the U.S. Food and Drug Administration (FDA) as a fast-moving, rapidly changing organization. However, their responsiveness to the public health risk of COVID-19 tells a different story. On February 4, 2020, the Secretary…
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Tips for Surviving a Virtual Audit

In the Coronavirus Era You May Experience Your First-ever Remote Audit Author: Amber Hilfiger, Director of Operations and Senior Quality Engineering Consultant Audits are unavoidable in the medical device industry. Even a global pandemic can’t stop them. While COVID-19 may have grounded planes, audits that provide the necessary checks and balances on quality systems, confirm…
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Get your Sterile Device to Market with Ease: Understanding Five Key Endotoxin Testing Requirements

By: Laura Lakemeyer, Senior Microbiology and Quality Consultant Important ST72:2019 updates can help ensure successful 510(k) submissions or avoid non-conformances The American National Standards Institute (ANSI) and the Advancement of Medical Instrumentation (AAMI) recently released substantial revisions to the updated standard ANSI/AAMI ST72:2019, Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing.…
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For manufacturers internal alignment is key to ensure quality throughout product lifecycle

QA Consulting CEO & Founder Anne Holland is featured in a Quality Magazine article focusing on the challenges medical device manufactures face in the ever-changing regulatory landscape. “Staying current with continually changing government and third-party regulations is tough,” Holland says. “But manufacturers can achieve consistent quality by aligning user requirements, design documentation, supply chain concerns,…
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QA Consulting, Inc. Presents at TMCx in Houston

Recently one of our Consultants, Amber Hilfiger, Director of Operations and Senior Quality Engineering Consultant presented to the newest cohort of start-up medical device companies selected for the Texas Medical Center Accelerator Program (TMCx) in Houston, TX.  The presentation was focused on educating early-stage companies on the key aspects of a medical device quality program. …
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FDA Inspection Trends: A More Collaborative Environment

QA Consulting has identified a shift in perception within the medical device industry regarding FDA inspections in recent years.  Specifically, manufacturers find that the agency’s investigators are fairer in their inspections and more tolerant of gaps when manufacturers demonstrate a proactive commitment to compliance and are actively working to remediate any gaps. The FDA’s data…
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