Blog

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

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…
Read more
Quality Systems, Regulatory Affairs
Permalink

Standards Updates: Risk Management for Medical Devices

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…
Read more
Quality Systems, Regulatory Affairs, Safety, Uncategorized
Permalink

Bioburden Basics for Sterile Medical Devices

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…
Read more
Microbiology
Permalink

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…
Read more
Audits, Quality Systems, Regulatory Affairs
Permalink

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…
Read more
Regulatory Affairs, Safety
Permalink

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…
Read more
Audits, Quality Systems, Regulatory Affairs
Permalink

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.…
Read more
Microbiology, Regulatory Affairs
Permalink

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…
Read more
Microbiology, Quality Systems, Safety
Permalink