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ISO 13485: understanding quality and regulatory compliance

On-Demand Webinar

ISO 13485 explained: requirements, benefits, and key differences

This webinar is designed to equip participants with a comprehensive understanding of ISO 13485 requirements. It focuses on the critical role of ISO 13485 in ensuring patient safety, meeting regulatory requirements, and its importance for global market access. Participants can explore the specific requirements of ISO 13485, its key difference from ISO 9001, and its applicability across various organizations.  

Key takeaways:

  • Understand the fundamental principles and requirements of ISO 13485 
  • Gain insights on the key differences between ISO 13485 and ISO 9001 
  • Learn how to apply ISO 13485 effectively across different organizational contexts to optimize quality management practices in the medical device industry.   

To watch the webinar, fill up the form. 

 

Our webinar will focus on:  

  • Overview of ISO 13485: Definition, key concepts, and guidelines 
  • Understanding the critical importance of ISO 13485 for your organization 
  • Specific requirements of ISO 13485 
  • Key difference between ISO 13485 and ISO 9001 
  • Q & A session

 

Dr. Vincent Lam

About the speaker

Dr. Vincent Lam

Senior Product Specialist & Technical Documentation Assessor

Vincent Lam develops and maintains device test programs for EU MDR conformity assessments and evaluates device documentation as a Technical Assessor. He is a lead auditor for Malaysian Medical Device Regulations, MDSAP and ISO 13485, with over 15 years of experience in assessing quality management systems, including validation data for terminal sterilisation, aseptic processing and sterile packaging.

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