Blog

Medical Device Expertise at Scale: Benefits of Outsourcing QA/RA Services

Author: Amber Hilfiger, Director of Operations and Senior Quality Engineering Consultant As the global demand for medical devices grows in parallel with a continually evolving regulatory landscape, the need for expert medical device outsourcing is stronger than ever. A recent market analysis report finds that medical device outsourcing is expected to grow at a compound…
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Standards Updates: Risk Management for Medical Devices

What’s New in ISO 14971:2019 and ISO/TR 24971:2020 Author: Silas Minnick, Senior Quality Engineering Consultant What’s in your ISO 14971 risk management plan? In December 2019, the latest revision to ISO 14971 was released. This standard specifies the terminology, principles, and processes related to the application of risk management for medical devices. While medical device…
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Bioburden Basics for Sterile Medical Devices

Author: Laura Lakemeyer, Senior Microbiology and Quality Consultant Assessing bioburden is a critical process monitoring step in the manufacturing of sterile medical devices. A product’s natural bioburden is an estimation of the microbiological contamination level of the device and is usually measured once manufacturing has been complete, but, prior to the sterilization process. Failure to…
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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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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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