Course Description

How to Navigate Through the ISO 13485 Certification Process

Course Description:

This course explains the quality system certification process for medical device manufacturers who wish to obtain ISO 13485 certification. It briefly examines the aspect of use of ISO 13485 in Europe for requirements from the Medical Device Directive.

The course also provides a step-by-step guide through the certification process, starting with manufacturers who already have a compliant quality system in place. It explains the role of certification bodies and accreditation requirements, and discusses which elements to take into account when choosing a certification body. Additionally, the course examines the steps of the certification process and the maintenance of the certification once it is obtained.

With regard to the European regulatory system, this course also explores the specific requirements of the MDD covered by the ISO 13485 system and additional aspects for CE certification reviews.

Learning Objectives:

Upon successfully completing this course, trainees will be able to:

  • Comprehend the certification process, its key players, and its impact
  • Discuss and plan a certification procedure with a certification body

Who Should Enroll:

Quality management staff unfamiliar with the ISO 13485 certification process, regulatory staff seeking a refresher in quality system certification, and management staff unfamiliar with quality system certification and wanting an overview are all welcome to participate in this course.

Prerequisite Knowledge/Requirements:

Completion of at least one of the following items is required:

  • Familiarity with an ISO 13485 quality system environment
  • Familiarity with ISO 13485 requirements
  • Successful completion of course ISO 13485:2016 - Medical Devices Quality Management Systems Requirements for Regulatory Purposes (ID 196)

Subject Matter Expert:

44 min

Related resources:

Case studies:

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