Healthcare and Medical Devices (ISO 13485) Training Courses

Learn how to design and develop medical devices to international quality standards such as ISO 13485, how to meet and keep ahead of medical device directive regulatory requirements, and gain knowledge of the CE Marking process. We also offer a wide range of specialist courses.

Our expert tutors are industry-leaders who have trained over 70% of the top 100 medical device companies globally, so you know you’ll be learning from the best.

Introduction to Risk Management for Medical Devices

Introduction to Risk Management for Medical Devices >

This course is designed to provide participants with an understanding of the impact that ISO 14971:2009 has on the decision making process at medical device manufacturing firms. This one-day training course helps medical device professionals gain an understanding of how ISO 14971 can improve their business and risk management efforts. Participants will also understand how ISO 14971 applies to ISO 13485.


1 Day Classroom training course

ISO 13485 Medical Devices and CE Marking Trainings

ISO 13485:2016 Medical Devices Quality Management Systems (IRCA Certified) Auditor/ Lead Auditor Course >

IRCA Certified Course (18190)

This course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485 and ISO 19011, “Guidelines for Quality and/or Environmental Management Systems Auditing.” Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results.


5 days classroom based training course

ISO 13485:2016 Medical Devices Quality Management Internal Auditor Training Course >

Learn how to audit the processes of an ISO 13485:2016 Quality Management System (QMS). This course provides guidance and practical experience in planning, executing, reporting and audit follow-up of an internal audit when monitoring the effectiveness and conformity of a ISO 13485:2016 compliant QMS.


2 days classroom based training course

Goods Distribution Practice for Medical Devices Training Course  >

  • Be equipped with the knowledge of medical devices fundamentals, GDPMDS requirements audit experience sharing and the implementation of GDPMDS in medical device manufacturing firms
  • Gain skills on how to prepare an execute an internal audit
  • Learn how to do corrective and follow up actions to improve your organization's GDPMDS efforts

2 days classroom training course