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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…

Audits, Quality Systems, Regulatory Affairs

June 24, 2020

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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.…

Microbiology, Regulatory Affairs

June 12, 2020

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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…

Microbiology, Quality Systems, Safety

March 25, 2020

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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,…

Quality Systems, Regulatory Affairs

March 18, 2020

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QA Consulting Hires Consultant Silas Todd Minnick

QA Consulting Hires Consultant Silas Todd Minnick Accomplished quality professional has extensive knowledge in multiple quality functions Austin, Texas - Feb. 21, 2020 – QA Consulting, Inc. has hired Silas Todd Minnick as a Senior Quality Engineering Consultant. Silas specializes in project management, quality system development, risk management, quality system remediation efforts, and post-market activities.…

Press Release

February 21, 2020

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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…

Quality Systems

January 10, 2020

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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…

Quality Systems

October 24, 2017

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