ISO 13485:2016 – Foundation Training CourseISO 13485:2016 / Foundation Training Course

ISO 13485:2016 - Awareness Training Course
A highly interactive 1 day ISO 13485 foundation training course that is designed to give delegates a sound knowledge of the requirements of ISO 13485 and the fundamentals of a medical device management system.

Duration - 1 Day

who should attend?

  • Executives and Senior Management
  • General Managers/Business Unit Managers
  • Quality and Regulatory Professionals
  • Management Representatives/Internal and External Auditors
  • Those seeking an understanding of the revisions


By the end of this ISO 13485 training course, delegates will be able to:

  • Interpret the basic requirements of ISO 13485 as it relates to quality management systems.
  • Apply the process approach to managing a company’s quality system, its control and effectiveness.
  • Compare ISO 13485 with ISO9001 and the FDA’s QSR requirements with the view of implementing the Standard.
  • Identify the importance of Design Control, Corrective and Preventative Action (CAPA) and Production and Process Control (P&PC) and how these can add value to processes.
  • Practical workshops are designed to reinforce the discussions and topics. This style of delivery makes the course both memorable and enjoyable for participants, ensuring long-term learning.


  • Introduction and overview of the requirements of ISO 13485
  • Comparison of the requirements of ISO13485 with FDA’S QSR and ISO9001 requirements.
  • Introduction to the Guide ISO/TR14969
  • Risk management requirements and ISO 14791
  • The implications of ISO 13485 for the Medical Device Industry in maintaining registration and market approval.
  • Analysis of a process-based management system and the impact this may have on a company’s procedural based system.
  • The approach of Regulators.
  • Sources of information and further development
how can we help you?

Contact us via email at [email protected] or submit a business inquiry online.

Thank you for an excellent course which was greatly enjoyed in all respects. It was a real “Crammer” but has undoubtedly fired my imagination as to what can be achieved.

Sue Haworth
Quality Manager, BNFL

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