ISO 13485:2016 Medical Device Quality Management System

NSF International teaches a variety of courses on ISO 13485:2016, Medical devices -- Quality management systems. ISO 13485:2016 is the international standard that defines quality management system requirements for organizations that are or may become involved in one or more stages of the medical device product lifecycle. This includes design and development, production, storage and distribution, and installation or servicing of a medical device, as well as design and development or provision of associated activities such as technical support. ISO 13485:2016 can also be used by suppliers or external parties that provide product and quality management system-related services to such organizations.

On-Site Training

This one-day course helps you better understand the requirements of ISO 13485:2016. You will learn:

• To understand the design specifications for the 2016 version of ISO 13485
• The difference between ISO 13485:2003 and ISO 13485:2016
• To comprehend the intent and meaning of all clauses of ISO 13485:2016
• To recognize the interrelationship and linkages between the clauses and requirements

Who Should Attend?

This course is vital for any medical device quality professional (including quality directors, managers, engineers and auditors) responsible for implementing a quality management system in accordance with ISO 13485:2016.

Trainer Profile

NSF's courses are taught by experts who have years of experience in medical device quality standards and regulatory requirements. Our trainers are committed to creating a learning environment that is highly interactive and based on real scenarios to help you apply practices and improve behaviors within your workplace. Learn more about our trainer for this course:

• Kim Trautman, Executive Vice President, Medical Device International Services