Course Description

Implications of EN ISO 14971:2012

Course Description:

This course focuses on Annexes Z of ISO 14971, which document the 2012 version of the standard’s changes in approach on how to apply the standard under the European Regulatory System. The course provides a general overview of the changes and outlines what they mean for both existing and future medical devices.

Learning Objectives:

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

  • Apply the approach explained in Annexes Z of ISO 14971: 2012 to current products and those within the same pipeline

Who Should Enroll:

Clinical affairs directors, clinical compliance, quality, and safety managers, clinical project managers, regulatory affairs coordinators and managers, quality assurance engineers and managers, manufacturing and R&D engineers, regulators, validation, design, and electrical safety engineers, internal, lead, and notified body auditors, CEOs, COOs, pre-clinical study managers, quality management, regulatory, and clinical research professionals, and professionals involved in the design, manufacturing, and validation of medical devices are all encouraged to participate in this course.

Prerequisite Knowledge/Requirements:

Learners should have a basic knowledge of risk management. 

The following courses are required:

  • ISO 14971: 2007 Review (ID 78)
  • Preparing Risk Management Files & Which Techniques Apply (ID 83)
  • Integrating Risk Management into Your Quality Management System (ID 94)

Subject Matter Expert:

28 min

Related resources:

Case studies:

Peer review:
Mindy McCann

Basic Account: € 94.00
Premium Account: € 70.00

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