GMDP-Sara-Adams

One of the main differentiators that makes Greenlight Guru so unique is its Guru Edge. The medical device gurus ⁠are a team of medical device professionals with decades of combined industry experience and subject matter expertise.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru at Greenlight Guru. Sara shares how her professional journey began as a biomedical engineer in the post-manufacturing industry. 

Listen as Sara offers valuable advice about her work as a quality engineer leading Corrective and Preventive Action (CAPA) investigations and implementations, process improvements, and supplier and regulatory audits.

 

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Some highlights of this episode include:

  • Sara believes that quality is the responsibility of all medical device professionals, regardless of role or function. Ultimately, her goal and dream is to help people.
  • As a guru, Sara enjoys listening to customers’ stories. She helps with onboarding them to achieve audit-readiness by leveraging Greenlight Guru’s QMS software to improve quality of life for patients. 
  • As a mom, Sara’s favorite stories involve customers working to change children’s lives and bring medical devices to market faster. She never loses sight that her family could be the patient on the table.
  • Studying biomechanics and watching surgeries peaked Sara’s interest in the medical device industry. She was not as interested in creating devices, as focusing on quality by following processes, procedures, and regulations.
  • Prior to joining Greenlight Guru, Sara was able to implement an electronic QMS to replace a company’s paper-based system. Change was the biggest challenge, but efficiencies and training documents were foundational in changing minds. 
  • The medical device industry has changed through the years. The auditing process in 2020 to 2021 changed the most by going from onsite to virtual audits. 
  • Keys to Success: Medical device companies and professionals need to be knowledgeable in ISO 13485 and 21 CFR Part 820 requirements and rely on resources.

 

Links:

Sara Adams

Sara Adams on LinkedIn

FDA - Medical Devices

FDA - Quality System Regulation Part 820

Notified Bodies

ISO 13485:2016

ISO 14971:2019

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable Quotes from Sara Adams:

“The coolest part to me is just listening to what they are creating and what vision they have in the medical device space.” 

“My favorite ones that come to mind are the ones that are working with children. As a mom, I never lose sight that my family could be the patient on the table.” 

“I love processes and procedures and helping people follow what regulations have been put in place and just coming up with solutions to do that in an efficient way and a cost-effective way, as well.” 

“We spent a lot of time training people and really helping them understand what the system could do for them that they would no longer have to rely on people to do.”

“Lightbulb Moment: When you get time back that you otherwise were spending doing things that didn’t bring a lot of value—or ultimately brought value—but when you’re having to chase something down, just not valuable of your time.”


ABOUT THE GLOBAL MEDICAL DEVICE PODCAST:

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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.