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Transitioning to ISO 13485:2016

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Seminar Content

ISO 13485 has been revised! The rational for the change was to provide an easily understood quality management system (QMS) standard for medical devices that is designed for regulatory purposes including supporting the future Medical Device Single Audit Program (MDSAP) goals and improving the alignment with EU Medical Device Directive (MDD) needs.

This class also covers the FDA 21 CFR 82030 for design control guidance for Medical Device Manufacturers, the section of the Food, Drug and Cosmetic Act relating to Medical Devices, Labeling for Medical Devices, US FDA QSR regulations and Good Manufacturing Practices (GMP), Post Market Surveillance, and Human Factors in Medical Device Design.

Key changes include:

“Life cycle of the product” added to the Scope;

Risk-based decisions and principles throughout the QMS;

Update of some requirements to current best practices based on previous Global Harmonization Task Force (GHTF) documents

GHTF was a voluntary group of representatives from national medical device regulatory authorities, i.e., the U.S. Food and Drug Administration (FDA) and the members of the medical device industry whose goal was global standardization of medical device regulation

It was disbanded in 2012 and replaced by the International Medical Device Regulators Forum (IMDRF) with no industry representation.

This one day class will include lecture, group and individual exercises.

Who Should Attend

This seminar is designed for Management representatives, process owners (e.g. Compliance, Purchasing, Technical Services, and Quality) in ISO 13485-certified companies and auditors.

Recommended Training and/or Experience

Good understanding of ISO 13485:2003 and minimum one year working in, or for the medical device sector. Those who do not meet these requirements should enroll in the “Understanding and Documenting ISO 13485:2016” course.

Seminar Materials

Participants will receive a hard copy of the presentation materials.

Seminar Goals

  • Discuss the differences between the 2003 version of the ISO 13485 standard and the 2016 revision.
  • Apply knowledge and understanding of the ISO 13485:2016 standard to begin implementation or update an existing Quality Management System to comply with ISO 13485:2016.

Seminar Outline

  • Patient Safety and Quality
  • What is ISO 13485?
  • ISO 13485 Revision
  • Terms and Definitions Impact
  • Key Changes
  • Group Exercise
  • Revision Timing
  • Assessing QMS Conformance


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