Is It Possible to "Buy" a QMS?

April 12, 2024


In this episode of the Global Medical Device Podcast, Etienne Nichols engages with Sara Adams to discuss Quality Management Systems (QMS) in the medical device industry.

The discussion unveils the complexities and common misconceptions surrounding QMS, drawing an intriguing analogy between building a QMS and crafting sourdough bread. Sara shares her extensive experience with FDA inspections and audits, emphasizing the essential, tailored approach needed for effective quality management.

Interested in sponsoring an episode? Click here to learn more!

Listen now:

Love this episode? Leave a review on iTunes!

Have suggestions or topics you’d like to hear about? Email us at

Key Timestamps

  • [02:15] - Sara recounts her experiences with FDA inspections.
  • [05:30] - Etienne introduces the sponsor and the episode’s focus on QMS.
  • [12:00] - Sara explains what a QMS is and is not, breaking down the layers of quality control.
  • [19:45] - Discussion on the practical steps to build and customize a QMS.
  • [34:10] - Sara’s sourdough analogy to illustrate the process of developing a robust QMS.
  • [48:55] - Examples of how different QMS systems can meet specific regulatory requirements.
  • [1:02:30] - Closing thoughts on keeping the patient in mind when building a QMS.

Latest MedTech Trends:

  1. Increasing regulatory scrutiny on how QMS are implemented.
  2. More companies are moving from paper-based to electronic QMS for better compliance and efficiency.
  3. Growing emphasis on customizing QMS components to fit specific medical device regulatory needs.

Practical Tips for Listeners:

  1. Understand the components of your QMS and ensure they align with regulatory requirements.
  2. Regularly review and update your QMS to adapt to new regulations and technologies.
  3. Consider electronic solutions for better traceability and compliance.


Memorable quotes:

  • "You can't buy a QMS off the shelf; it's like trying to bake sourdough bread without understanding the process or the ingredients." – Sara Adams
  • "The patient should be the focus of everything we do in the medical device industry." – Sara Adams


Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at


This episode is brought to you by Cleio Medical Device Design. Discover how Cleio can transform your medical device concepts into market-ready products at

About the Global Medical Device Podcast:

Untitled (8.5 × 3 in)

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.

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

Search Results for:
    Load More Results