Event info
Date:27 Oct
Time:9:00 - 10:00
Venue:Online
Contact person
Nicole Mastrell

Nicole Mastrell

Event Manager & PA to CEO

nm@mva.org

+45 6141 8634

MVA Inspirational Webinar Series – What does it mean to be ISO 13485 compliant?

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
Venue: Online

 

SIGN UP

 

Program

 

9:50Online platform opens for registering participants 
10:00Welcome
David Munis Zepernick, Head of Business Development and Public Affairs, Medicon Valley Alliance
10:05What does it mean to be ISO 13485 compliant?
Linda Kellberg, Specialist, Product and Process Compliance, Innokas Medical Ltd
10:50Q&A
11:00End of webinar

 

 

Speaker

 

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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