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Fundamentals of Risk Management for Medical Devices

4-weeks | 1 hour per week

Starts 4 March 2019

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.

What is an Online Academy course? 

Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.

The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning.

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

What happens during an Online Academy course?

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This online academy course can be accessed from 4 March 2019. 1 module will be uploaded per week, allowing you to study at your own pace. Your trainer will welcome any questions that arise throughout your course.

Please note that full payment must be made prior to the course start date in order to receive your login details to begin the course.

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