Medical Devices Training

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 specialistcourses.

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.

Not sure which course is for you? We have a range of complimentary webinars to help you decide.

ISO 13485 training

Introduction & Implementing ISO 13485 Medical Devices training course >

  • ISO 13485 shapes quality management systems for medical device manufacturers the world ever
  • W will explain how ISO 13485 is implemented and draw links with other quality standards
  • BSI's Implementing ISO 13485 course has been designed to provide you with the knowledge and process steps to enable them to effectively implement a Quality Management System in line with the requirements for ISO 13485 certification. The course introduces the concepts needed to understand, develop, and implement a quality management sytem

3 days classroom based training course

Internal Auditor for ISO 13485 >

  • BSI's Internal Auditor ISO 13485 course is intended for medical device quality professionals aiming to build on their current knowledge of ISO 13485 and evaluate the effectiveness of the quality management system in their organization. This intensive course teaches the principles and practices of effective quality management systems process audits in accordance with the ISO 13485 and ISO 19011. An experienced instructor guides students through the internal audit process, from planning an audit to reporting on audit result and following up on corrective actions.
  • Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing and group workshop.

3 days classroom based training course