What is the webinar about?

Join us for our engaging and informative webinars, “ISO 13485 – A Beginners Guide,” designed to provide a comprehensive introduction to this essential standard. 

In this beginner-friendly session, we’ll demystify ISO 13485:2016, the international standard for quality management systems (QMS) specifically tailored for the medical device industry and supporting contract manufacturers. Our expert speakers will guide you through the fundamental principles, requirements and benefits of implementing ISO 13485 within an organization.

What will participants gain?

  • An understanding of ISO 13485: Get to know the purpose and scope of the standard, and why it’s critical for ensuring the safety and effectiveness of medical devices. 
  • Core requirements: Learn about the key elements of ISO 13485, including documentation, risk management and process controls
  • Implementation steps: Discover practical tips and timelines for starting your journey towards ISO 13485 certification. 

 

Who should attend?

  • Newcomers to medical device quality management
  • Quality professionals looking to broaden their understand of ISO 13485:2016
  • Those interested in pursuing ISO 13485:2016 certification
     

Speakers

Greg
Jones 
Head of Assessment Delivery
 

To find out more about ISO 13485 visit our dedicated ISO 3485 webpage and follow us on LinkedIn at BSI Medical Devices

Email: us.medicaldevices@bsigroup.com

Phone: +1 800 429 6178

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