#371: Achieving ISO 13485 Certification

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.Key Timestamps00:00 - 02:00 - Introduction by Etienne Nichols02:00 - 05:30 - Introduction to HTD Health and their focus05:30 - 10:45 - Discussion on the importance of ISO 13485 certification10:45 - 14:30 - Steps and preparations for achieving ISO 13485 certification14:30 - 20:00 - Benefits and features of using Greenlight Guru’s eQMS20:00 - 25:00 - Challenges and changes faced during the certification process25:00 - 30:00 - Practical tips for preparing for an ISO 13485 audit30:00 - 35:00 - Continuous improvement and future goals for HTD Health35:00 - 40:00 - Closing thoughts and advice from Weonika Michaluk and Zach MarkinNotable QuotesWeronika Michaluk: "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."Zach Markin: "In services, there’s not one ideal agile, but the right flavor of agile for the work that needs to be done."Weronika Michaluk: "Using Greenlight Guru made our lives easier, especially in managing traceability and ensuring compliance."Key TakeawaysPractical Tips for MedTech EnthusiastsGap 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.ReferencesISO 13485 Certification: Learn about the ISO 13485 standard for medical devicesVisit Greenlight Guru for eQMS software solutionsHTD HealthWeronika Michaluk on LinkedInZack Markin on LinkedInConnect with Etienne Nichols on LinkedIn.MedTech 101Explainer for New ListenersISO 13485: An international standard that outlines the requirements for a quality management system specific to the medical device industry. It ensures that organizations consistently meet customer and regulatory requirements related to medical devices.QMS (Quality Management System): A structured system of procedures and processes covering all aspects of design, manufacturing, and distribution to ensure products meet regulatory standards and customer expectations.CAPA (Corrective and Preventive Action): A process within a QMS to investigate and correct the root causes of identified issues and prevent their recurrence.Audience EngagementPoll QuestionWhat MedTech innovation are you most excited about?Email your thoughts to