Professional Training

Medical Device Risk Management

PTI, Online
2 days
2 days
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Course description

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 EN ISO 1497 and its overlap with ISO 13485 and the new 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.

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Suitability - Who should attend?

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

Training Course Content

  • 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 1471:2012, ISO 13485:2012, 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

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:


85% had applied content during the course to their role

Delivery rating:


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