Category Archives: Regulatory Affairs

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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UDI Final Ruling Makes Its Debut

Top 10 Differences Between the Proposed and Final Rules In June 2013, QA Consulting presented “Unique Device Identifier: Update and plan for the future” at MD&M East based on the Proposed Rule. With the release of the UDI Final Rule on September 24th 2013, we want to share our “TOP TEN” differences between the Proposed…
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Updating to ISO 14971:2012

Are You Late to the Game? Fourteen months ago, the updated “BS EN ISO 14971:2012 Medical Devices – Application of risk management to medical devices” standard was released and became effective immediately.  Despite the recently passed anniversary for the effectivity of this updated standard, many medical device manufacturers have yet to update their risk management…
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What the FDA Wants You to Know

Takeaways from the FDA Small Business Regulatory Education for Industry (REdI) Conference  QA Consulting attended the FDA Small Business Regulatory Education for Industry (REdI) Conference held September 25-26, 2013 in Bethesda, Maryland.  Pre-submission, quality system, and post-market topics were covered by FDA staff.  Below are our key takeaways from the meeting by topic. General While…
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