(How I learned to love quality and you can too!)
Author: Anne Holland, CEO and Founder
It’s hard to believe that it has been 20 years since I hung out my shingle and launched QA Consulting, Inc. here in Austin, TX. I count it as a privilege to have helped our clients get their medical devices to market safely and with a keen focus on quality. To date, I’m proud to say we’ve worked with over 200 clients on more than 500 medical device products.
The only constant has been that every day brings a new challenge. Advances in technology combined with a continually evolving regulatory landscape have transformed the medical device industry. Throw in a global pandemic and the promise of 5G, and I don’t foresee slowing down anytime soon.
Our commitment to educating manufacturers on the nuances of the quality and regulatory requirements has been a cornerstone of our work. As I like to tell clients, we are quality connoisseurs that help you jump through compliance hurdles with ease.
It’s gratifying to develop custom medical device quality systems, regulatory affairs, or microbiology analysis strategies that help a manufacturer achieve their business goals while ensuring that their products are safe and effective. Whether it’s a startup that brings their product idea on the back of a napkin or a multinational company, we’ve got the expertise and PM skills to see projects through.
Read on to learn about some of the innovations and regulatory changes I’ve witnessed during the past 20 years, my predictions for the future, and how a carefully cultivated team of experts has helped QA Consulting exceed client expectations of a service provider.
Technology-Driven Medical Device Innovations
One of the most exciting developments I’ve witnessed during the past two decades has been the fast pace of technological innovations to help people live healthier lives.
For example, the rise of wearable devices makes remote patient monitoring easier than ever while also keeping patients more engaged in their health by getting real-time data into the hands of their providers.
Implantable medical devices with a technology component, including those that deliver medication and remotely monitor a patient’s medical data, are changing the way doctors help improve their patient’s quality of life.
As mobile 5G technology promises to make further innovation possible and medical devices get smarter, smaller, and become part of our daily lives with wearable devices and other advances, manufacturers cannot afford to turn a blind eye to quality systems, regulatory affairs, and microbiology needs.
Considering the rapid pace of technological advances, it has been heartening to see the U.S. Food and Drug Administration enact regulatory changes to keep pace with new technologies to ensure products are safe for consumers.
Regulatory Changes in the EU
We’ve been keeping a close eye on the European Union as it goes through a massive regulatory change that impacts how the medical device industry operates with the transition from the MDD to the MDR.
Under the Medical Device Directive, the EU provided simply that, a series of directives. The Medical Device Regulation of 2017 is not only more complex but is now an enforceable set of rules that manufacturers must follow. After a delay due to the pandemic, the EU has set a new date of May 26, 2021, for the new regulations to take effect and the QA Consulting team is prepared to help our clients navigate this new regulatory landscape.
Permanent Pandemic Changes
While none of us predicted the impact the COVID-19 outbreak has had on the global workforce, it has kick-started changes in the medical device industry that will likely outlast the pandemic.
Most notably has been the adoption and acceptance of virtual audits. While virtual audits are not new to our industry, during the pandemic, Notified Bodies, including BSI Group, TUV SUD, UL, and others, ramped up their efforts.
The widespread adoption of the processes and procedures for conducting virtual audits are likely to stay with us as they’ve proven effective while simultaneously lowering costs and increasing efficiencies.
Your Team of Quality and Regulatory Experts
Cultivating a team of medical device quality consulting experts with multiple certifications over the years has proven quite gratifying. When you partner with QA Consulting, the individuals you meet during the sales process are the ones rolling up their sleeves to do the work. There’s no bait and switch like some of the larger consulting firms that introduce you to veteran consultants only to swap them out for more junior ones once the project is underway.
Each team member is committed to educating clients on the process and procedures for success, supported by expert documentation. Ideally, we put in place a quality system that you can follow with or without our continued guidance and support.
You can feel confident in our 20 years of experience, during which we have:
- Led 300+ audits
- Handled 45+ 510(k) FDA premarket submissions
- Designed and implemented 50+ quality management systems
Company certification and individual credentials are at the heart of our organization. We’re one of the few medical device consulting firms of our size that is ISO 13485 certified. I encourage you to review our complete book of credentials.
Lean into our Quality, Regulatory, and Microbiology Know-How
We’ve had an exciting 20 years here at QA Consulting, as I recount in this video. I am thankful for the many clients who have put their trust in our team. Will you be a part of our next 20 years? I certainly hope so!
Contact us today to talk to an FDA consulting or medical device regulatory affairs consulting expert and let us be part of your success story.