News

Risk Based Approach for Medical Device Quality Management

Risk Based Approach for Medical Device Quality Management
Quality Magazine recently published an article “A Risk Based Approach For Medical Device Quality Management” written by Anne  Holland, CEO and Founder of QA Consulting, Inc. The team at QA Consulting has provided personalized consulting services for early stage, mid-size and Fortune 500 medical device companies for over 15 years. ISO 13485:2016 Medical devices — Quality…
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Quality Systems
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QA Consulting, Inc. Presents at TMCx in Houston

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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Quality Systems, Regulatory Affairs
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QA Consulting, Inc. Receives ISO 13485:2016 Certification for Medical Device Consulting Services

Austin, TX, May 19, 2017 - QA Consulting announced today that it has received ISO 13485:2016 certification  to provide medical device consulting services for quality management system (QMS) implementation and maintenance, regulatory affairs, and microbiological services following a successful audit conducted by the BSI Group. “We are proud to be one of the first medical…
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Press Release
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Dissecting the FDA’s Expectations for Biocompatibility of Medical Devices: Five Key Considerations

The FDA issued a long-awaited final guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process replacing the historical "Blue Book Memorandum #G95-1" (1995). The new guidance, released in June, is a substantial upgrade from its predecessor and serves the purpose of guiding…
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Microbiology
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Five Strategies for Effective Supplier Management

Medical device manufacturers commonly use outsourced suppliers for device components, assembly, packaging, labeling, and sterilization. An outsourced supplier may even produce the entire finished device under the manufacturer’s brand name. In all of these instances, it is ultimately the manufacturer’s (specification developer’s) responsibility, not the outsourced supplier, to ensure that the devices meet all specifications. To meet this responsibility,…
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Quality Systems
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Human Factors: Integrating the Human Condition into Medical Device Design

Human factors and usability engineering are synonymous terms which describe the application of knowledge about human behavior toward the design of a device. Understanding that human behavior can easily result in adverse events with medical devices, the FDA recently issued the guidance document, Applying Human Factors and Usability Engineering to Medical Devices, to provide recommendations…
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Quality Systems
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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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Quality Systems, Regulatory Affairs
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