MDTI is part of the Knowledge & Networking Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa

Fundamentals of Risk Management for Medical Devices

4-weeks | 1 hour per week

3 February - 6 March 2020

Online Academy

Risk management is a complex but necessary process for medical device companies, and its complexity has only heightened with the introduction of more stringent regulatory requirements under ISO 14971 and the Medical Device Regulation (MDR). It is crucial to learn how to correctly modify your approach, so that you are harmonised with the new Regulations and can guarantee your compliance.

This online course will provide you with a complete overview of the key regulatory considerations for risk accompanied by the tools and techniques you can use to implement them, for both professionals new to the area and those who need an update on the latest developments. You will be able to cement this knowledge through an entire module on case studies based off the trainer’s own experiences, so you can practically apply the information you have learned.

Richard Young

Richard Young has over 20 years’ experience in the medical device industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited

  • Understand the importance of ISO 14971 and how to apply it to your own processes
  • Identify links between ISO 14971 and ISO 13485
  • Improve your understanding of the risk requirements under the MDR and distinguish its differences from the MDD
  • Develop your skills in risk management planning by learning about key methods for project management

This course will be useful for personnel involved in risk assessment and risk management activities, and for those who are new to the industry and need a complete overview of the medical device regulatory framework in the EU. It will be applicable for professionals in:

  • Regulatory affairs
  • Quality assurance
  • Product managers
  • Design engineers
  • Clinical staff
  • Project managers

MDTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.


Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.

Watch the Online Academy Video

You may also be interested in...

Medical Device Regulatory Project Management
2-day course | 25 - 26 February 2019 | London

Medical Device Risk Management
2-day course | 26 - 27 June 2019 | London