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ISO 13485:2016 Course Registration

ISO 13485:2016, quality management for medical devices

A practical course by Yallow Life Science
📅 18 November 2026
📍 Forskningsparken, Gaustadalléen 21, Oslo
👩‍🏫 Course leader: Amrita Kaur, Senior QA/RA Advisor, Yallow

About the course

ISO 13485 is the harmonized standard for quality management systems under MDR and IVDR. This course gives you a practical understanding of the requirements, and how to build a system that works in daily operations.

What you will learn

• The requirements of ISO 13485:2016, clause by clause
• How ISO 13485 links to MDR and IVDR
• The risk based approach and risk management
• Design and development, documentation and traceability
• Supplier control and outsourced processes
• Nonconformities, CAPA and continual improvement
• Internal audits and preparing for certification

Who should attend

Founders, startups, quality and regulatory staff, product developers and managers in medtech and life science.

Price per participant

• NOK 5,500 for members of Norway Health Tech, Aleap and Forskningsparken
• NOK 6,500 for others

Full Name

Company/Organization

Email Address

Phone Number

Membership Status

Member of Norway Health Tech, Aleap or Forskningsparken (NOK 5,500)

Standard (NOK 6,500)

Registration Confirmation

By clicking Submit, I confirm my registration for this course. I understand that this registration is binding.