Singapore | EN

ISO 13485: Understanding quality and regulatory compliance

On Demand

Webinar

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 organisational contexts to optimise quality management practices in the medical device industry

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 organisations.

To view the webinar, fill in the form now.

Our webinar will tackle these points, focusing on

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

 

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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