Understanding ISO 13485:2016

Course Description
ISO 13485:2016 medical devices training focuses on 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.

This virtual course fully covers the ISO 13485:2016 requirements clause-by-clause.

You will apply and interpret ISO 13485:2016 and know what’s different about this standard from ISO 9001. This class also covers the comparable 21 CFR 820 content for additional guidance for organizations in the Medical Device sector.

The course is especially designed for auditors, supervisors, and managers in the medical device industry.

Learning Objectives

  • Review ISO 13485:2016 requirements clause-by-clause.
  • Describe the conformity assessment process.
  • Analyze the quality management systems for nonconformities.
  • Explain quality management system terminology.

Agenda – 10am-1pm each day

  • Class Rules / Logistics
  • Overview
  • Implementing ISO 13485:2016
  • Clause-by-clause review of the ISO 13485:2016
  • Documentation Requirements
  • Continual Improvement

Payment Type
Date Attending
Name of Attendee(s)
Name of Company



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