Achieving ISO 13485 Certification

June 6, 2024


In this episode of the Global Medical Device Podcast, host Etienne Nichols chats with Weronika Michaluk and Zach Markin from HTD Health about their journey to achieving ISO 13485 certification.

The discussion covers the importance of gap analysis, the value of a compliant agile approach, and the benefits of using Greenlight Guru’s eQMS software. Listeners will gain valuable insights into maintaining compliance and continuous improvement in the MedTech industry, as well as practical advice for navigating ISO 13485 certification.

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Key Timestamps

  • 00:00 - Introduction by Etienne Nichols
  • 02:00 - Introduction to HTD Health and their focus
  • 05:30 - Discussion on the importance of ISO 13485 certification
  • 10:45 - Steps and preparations for achieving ISO 13485 certification
  • 14:30 - Benefits and features of using Greenlight Guru’s eQMS
  • 20:00 - Challenges and changes faced during the certification process
  • 25:00 - Practical tips for preparing for an ISO 13485 audit
  • 30:00 - Continuous improvement and future goals for HTD Health
  • 35:00 - Closing thoughts and advice from Weonika Michaluk and Zach Markin

Practical Tips for MedTech Professionals

  1. Gap Analysis: Conduct a thorough gap analysis to understand current capabilities and areas needing improvement.
  2. Internal Expertise: Ensure you have the necessary internal expertise or consult with experienced partners.
  3. Continuous Improvement: Regularly update and improve your processes to maintain compliance and efficiency.


Memorable quotes

  • "Do a proper gap analysis and also think whether you have enough knowledge will make your life easier to reach out to a partner or consultant." - Weronika Michaluk
  • "In services, there’s not one ideal agile, but the right flavor of agile for the work that needs to be done." - Zach Markin
  • "Using Greenlight Guru made our lives easier, especially in managing traceability and ensuring compliance." - Weronika Michaluk


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

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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...

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