ISO 13485:2016 Medical Device QMS Training

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.

Poor management of processes at any phase of the medical device lifecycle can result in inconsistency in the quality of products, and those poor quality devices can filter through the production line and into the market, drastically impacting your customers and your company. However, when quality management processes are properly managed under an ISO 13485:2016-certified quality management system, medical device manufacturers and their supply chain are better equipped to ensure that quality system requirements protect all phases in the medical device lifecycle. ISO 13485:2016 also provides an effective base model for compliance with:

• European Medical Devices Directive (MDD) 93/42/EEC
• European In Vitro Medical Devices Diagnostic Directive (IVDD) 98/79/EC
• Canadian Medical Devices Regulations SOR/98-282
• Medical Device Single Audit Program (MDSAP)
• Requirements of other regulatory bodies in countries around the world

Sample Agenda

The agenda for our ISO 13485:2016 training class might look like this:

• Welcome and introductions
• ISO 13485:2016 design specifications
• ISO 13485:2016 clauses 1-4
• ISO 13485:2016 clauses 5-6
• ISO 13485:2016 clauses 7-8
• Regulatory transitions
• Questions and answers

Learning Outcomes

Upon completion of this course, you will:

• Understand the design specifications for the 2016 version of ISO 13485
• Learn the differences between ISO 13485: 2003 and ISO 13485: 2016
• Comprehend the intent and meaning of all clauses of ISO 13485:2016
• Recognize the interrelationship and linkages between the clauses and requirements

Who Should Attend?

This course is vital for any medical device quality professional, as well as quality directors, managers, engineers and auditors who implement their quality management system.

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 trainers for this course:

• Kim Trautman, Executive Vice President, Medical Device International Services
• James Pink, MCQI, CQP, Vice President, Europe, Health Sciences Medical Devices