Category Archives: Quality Systems

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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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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New study indicates Coronavirus can linger for three days on plastic and stainless steel

What should we do if a returned product comes back  potentially contaminated? What if an employee tests positive for COVID-19? In the wake of the coronavirus pandemic, clients have been contacting QA Consulting over the past few weeks with important questions. If your company receives a medical device shipment back from a customer such as…
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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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Four Dangerous Myths about Quality that May Cost Lives

Quality is often misunderstood. More specifically, the benefits of a well implemented quality management system (QMS) are not universally known and appreciated, and that can cost lives. Conversely, when executives and manufacturing personnel understand the benefits of a QMS, patient outcomes improve, the quality of life is enhanced, and manufacturers prosper. In the medical devices…
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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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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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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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