Achieving ISO 13485 Certification

June 6, 2024

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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

Gap Analysis: Conduct a thorough gap analysis to understand current capabilities and areas needing improvement.
Internal Expertise: Ensure you have the necessary internal expertise or consult with experienced partners.
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 internally...it 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

Feedback

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

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.

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Etienne Nichols

Etienne Nichols is the Head of Industry Insights & Education at Greenlight Guru. As a Mechanical Engineer and Medical Device Guru, he specializes in simplifying complex ideas, teaching system integration, and connecting industry leaders. While hosting the Global Medical Device Podcast, Etienne has led over 200...