The ISO 13485 sets out the requirements for a quality management system specific to the medical devices industry. Why should you have a QMS in the first place, and why use the ISO 13485 standard?
We’ll share hands-on experience on what the standard means in practice, as well as ideas on how you can ensure and maintain compliance with it.
If you’re working to define a QMS, or planning to do so, join and listen to our tips on what to consider on that road.
Date: Wednesday 27th October 2021
Time: 9:00 – 10:00
|9:50||Online platform opens for registering participants|
David Munis Zepernick, Head of Business Development and Public Affairs, Medicon Valley Alliance
|10:05||What does it mean to be ISO 13485 compliant?|
Linda Kellberg, Specialist, Product and Process Compliance, Innokas Medical Ltd
|11:00||End of webinar|
|Linda Kellberg Specialist, Product and Process Compliance, Innokas Medical Ltd|
Linda Kellberg (M.Sc.) has over 8 years of hands-on experience in medical device design controls, quality management systems, and regulatory affairs. From the very beginning of her career, Linda has been working in the medical device industry developing, implementing, and maintaining quality management systems and related processes. In addition, Linda has been managing numerous market clearance processes of medical devices in both the EU and the US. Linda has worked with different types of medical devices from software only devices to complex Medical Electrical (ME) equipment.
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