ISO 13485: Requirements and Implementation

20% discount for Registration of 2 or more participants. 

Course Overview
This interactive online course is designed for the professionals who need to understand, implement and maintain ISO 13485:2016, the international standard for Quality Management Systems in medical device industry. Delivered live by a high experienced trainer, the course combines presentations, real-world case studies, practical workshops, and Q&A sessions to ensure participants gain both knowledge and hands-on experience.

What You Will Learn

• Key requirements of ISO 13485:2016 and how they implement in your organization
• Practical steps for implementing and maintaining a compliant QMS
• Integration of risk management and applicable regulatory requirements (EU MDR, FDA, TGA, etc.)
• Documentation structure and best practices for efficiency and compliance
• How to prepare for audits and avoid common nonconformities

Interactive Features

• Workshops: Practical exercises to apply ISO 13485 requirements to real scenarios
• Q&A Sessions: Dedicated time to discuss participant questions and specific challenges
• Live Discussions: Opportunities to share experiences and learn from peers

Who Should Attend

• QA/RA professionals in medical devices
• Manufacturers, suppliers, and startups entering the MedTech sector
• Consultants, auditors, and project managers

Course Benefits

• Live, interactive learning with industry insights
• Practical tools and templates you can use immediately
• Certificate of Completion

Format: Live online sessions with workshops and Q&A

Duration: 2 Days (16 hours) 

Dates of Training course: 27th & 28th Nov. 2025

Trainer: Hasan Zarin Mehr, with over 18 years of experience in the medical device industry, has served as a Principal Consultant and worked with Notified Bodies as a Lead Auditor and Technical Documentation Assessor for standards and regulations including ISO 13485, MDSAP, EU MDR, UKCA, and more.
With a background in Biomedical Engineering, he brings deep practical expertise, delivering training that combines real-world scenarios with actionable, experience-based solutions.