News

Press Release – QA Consulting, Inc. Receives ISO 13485:2003 and ISO 9001:2008 Certification

PRESS RELEASE Austin, TX, May 30, 2014 — (QA Consulting, Inc), a medical device consulting firm, has received ISO 13485:2003 and ISO 9001:2008 certifications. QA Consulting’s achievement is the result of implementing a vigorous quality management system designed to govern their consulting and contract manufacturing services. These certifications serve as an important milestone in assuring…
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Press Release – QA Consulting, Inc. is WBENC Certified

PRESS RELEASE (Austin, TX) – (October 29, 2013) – (QA Consulting, Inc.), a business specializing in, providing quality, regulatory, and microbiology consulting services to the medical device industry, received national recognition as a Women’s Business Enterprise by the Women’s Business Council – Southwest Certification Committee, a regional certifying partner of the Women’s Business Enterprise National…
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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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Process Validation Insight

5 Elements for Success Medical device manufacturers are facing increased customer and regulatory scrutiny regarding process validation. Process validation is a regulatory requirement per 21 CFR Part 820.75 and ISO 13485:2003 Section 7.5.2. For example, at least 37 FDA warning letters have been issued to date in 2013 related to process validation for medical device…
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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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