Welcome to the premier issue of our new and improved quarterly newsletter, the Device Discourse!

The QA Consulting team is dedicated to providing you with relevant and timely quality systems, regulatory affairs, and microbiology news and information from across the medical device industry. 

With 20 years of experience in the field, you can trust that our team has the knowledge and expertise for whatever challenges are ahead in 2021. 

From guiding your organization through a notified body audit and developing your SOPs, to writing sound biological evaluation reports or implementation of the E.U. Medical Device Regulations, you can depend on QA Consulting to help you avoid regulatory roadblocks and costly product delays. We can even be your entire outsourced quality department.
Best,
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Avoid the 3 Most Common Mistakes in Your Next Biological Evaluation Report (BER)

Every medical device that has patient contact, whether direct or indirect, must consider the biological endpoints of cytotoxicity, sensitization, and irritation. 

Get our tips for developing expert biological evaluation reports (BERs).

Is Outsourcing Your QA/RA Services Right For Your Organization? 

If your company needs the ability to scale your quality assurance and regulatory compliance staff while also tapping into specialty expertise, then outsourcing to a trusted partner might be the best option for achieving your business goals.

Learn about the problems that outsourcing can help your organization solve and determine if outsourcing is right for you. 
Get to Know Our Experts

Three Questions with
Silas Minnick,
QA Consulting Senior Quality Engineering Consultant
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1. What is your primary area of medical device expertise?

My role at QA Consulting draws on my nearly 30 years of quality engineering experience in the areas of:
  • New product development
  • Sustaining product support
  • Quality Management Systems (QMS)

I feel fortunate that my career path has allowed me to work with various products, including IVDs, orthopedics, and cardiac devices. This experience has helped me to expand my skill set to include process validations, metrology, quality audits, problem-solving (CAPAs), engineering specifications (GD&T), supplier management, and regulatory affairs.  

2. What medical device innovations are you most excited about in 2021? 

With the entire world being exposed to COVID-19 in 2020, I anticipate an increased application of IoT (Internet of Things).  

3. What’s one thing we’d be surprised to know about you? 

I have always enjoyed giving back to my profession by volunteering. Over the years I have been Chair of the Austin Section of the American Society for Quality (ASQ) and the Central Texas Section of the American Society of Mechanical Engineers (ASME).

I was also an Examiner and Judge for the University of Texas Center for Performance Excellence (UTCPE) during which I conducted audits of companies seeking a local version of the Malcolm Baldrige Quality Award.   

Throughout my career, I have felt that giving back to your profession is the proper thing to do to help future generations of Quality professionals succeed in their own careers.  
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FDA Corner
Draft guidance on the electromagnetic compatibility (EMC) of medical devices is open for public comment until January 19, 2021.

COVID-19 tests and collection kits authorized by the FDA.
Lean into quality with medical device systems everyone can trust.
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