ISO 13485: Understanding Quality and Regulatory Compliance

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  

ABOUT THE SPEAKER 

Dr. Vincent Lam
Senior Product Specialist and Notified Body Medical Device Technical Documentation Assessor 

Vincent Lam is responsible for establishing and maintaining device test programs to facilitate assessments of devices and technologies under the European Medical Device Regulations (EU MDR) conformity assessment schemes. As Technical Assessor, he evaluates evidence of compliance of device related documentation submitted for the purpose of EU MDR conformity assessment. In addition, he is currently a lead auditor for Malaysia Medical Device Regulations, MDSAP and ISO 13485. He has more than 15 years of experience in evaluating quality management system audits including validation data and outputs related to terminal sterilisation, aseptic processing, and sterile packaging.  

Learn more about ISO 13485 Quality Management System for Medical Devices we offer.