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Medical Device Risk Management

Updated to reflect the ISO 14971: 2019 Standard

2 - 3 November 2020

Radisson Blu Edwardian Grafton, London

Are you up-to-date with new risk management requirements?

Risk Management is an important but difficult concept for lots of industries but is particularly important within the medical field and hence within medical devices. In such a hazard-rich industry, risk must be considered from the beginning to the very end of a product lifecycle. Implementing risk has never been more challenging, as recent regulatory changes have made it problematic to harmonize risk management processes in product lifecycles. Therefore, it has never been more important to understand how to coordinate an effective risk management strategy.

This interactive course offers a comprehensive and up-to-date overview of the regulatory requirements for risk management of medical devices and provides an insight into a variety of tools and techniques to implement them into your own systems. Attendees will be provided with an in-depth outlook on ISO 14971:2019 and its overlap with ISO 13485:2016 and the new Medical Device Regulation (MDR), alongside gaining an informed insight into the intricacies of risk management planning. Overall, attendees will expect to be taken through the risk management process from start to finish.

  • Update your knowledge of the risk requirements in the new MDR
  • Gain a comprehensive overview of the global regulatory standards for risk management, including ISO 14971:2019, ISO 13485:2016, EN ISO 62366-1 and critically referenced standards such as EN ISO 10993-1 and ISO 14644
  • Develop your skills in risk management planning by practically applying a variety of tools and techniques to case studies
  • Learn how to effectively analyse ongoing risk management activities such as PMS and clinical investigations and enhance your understanding of their regulatory procedures.
  • Improve your understanding of the regulatory requirements and procedures in a Quality Management System
  • Cement your knowledge through group discussions, case studies and interactive exercises

Matthew Theobald

Matthew has over 25 years’ experience working at strategic, site and project levels with organisations across Europe and the US. He has worked in medical device, combination product and pharmaceutical development and Quality Management. Matthew has presented at conferences throughout Europe, delivered more than 70 training events, co-authored two books about Human Factors for Medical Devices, including “How Humans Factor (in medical device design)” and one on project leadership. Matthew is currently the Director of New Product Development at his own Consultancy Firm, Three Circles.

This course will be useful for personnel involved in risk assessment and risk management activities, and for those who need a complete in-depth overview of the medical device regulatory framework for risk management throughout the entire device lifecycle. It will be applicable for professionals in:

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

Related Webinars

ISO 13485:2016 – An Overview of General and Product Realisation Requirements

Led by Richard Young, trainer for MDTI's 'Managing the Transition to the new IVD Regulation' and 'Practical Guidance for Medical Device Audits and Inspections' courses, this c. 20 minute webinar covers:

- Impacts of the new revision
- New terminology
- General requirements
- Resource management
- Product realisation and design controls
- Q&A session

Medical devices software development and applications

Over c.30 minutes, this webinar explores a major area of development from the last decade. Presented by Richard Young, it covers:

- The changing regulatory environment for medical devices in Europe 
- FDA regulation 
- Key considerations in development environments 
- Key standards 



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