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What to Look for in a Medical Device Quality and Regulatory Compliance Consulting Partner: The Definitive Checklist

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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Audits, Quality Systems, Regulatory Affairs
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Navigating the FDA Emergency Use Authorization (EUA) Requirements for PPE and Medical Devices

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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Regulatory Affairs, Safety
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Tips for Surviving a Virtual Audit

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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Audits, Quality Systems, Regulatory Affairs
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Get your Sterile Device to Market with Ease: Understanding Five Key Endotoxin Testing Requirements

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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Microbiology, Regulatory Affairs
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New study indicates Coronavirus can linger for three days on plastic and stainless steel

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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Microbiology, Quality Systems, Safety
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For manufacturers internal alignment is key to ensure quality throughout product lifecycle

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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Quality Systems, Regulatory Affairs
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QA Consulting Hires Consultant Silas Todd Minnick

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.…
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Press Release
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Four Dangerous Myths about Quality that May Cost Lives

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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Quality Systems
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