Practical Risk Management for Software Devices

OVERVIEW

Please note: The event date has been changed to Wednesday 8th November. 

Whether working on software as a medical device, or a health software application, appropriate risk management at all stages of the product lifecycle is essential to ensure patient safety, user safety, and regulatory compliance. The ISO 14971 and DCB0129 standards provide frameworks to identify, estimate, evaluate, monitor, and control the risk of software-based medical products. Therefore, a good understanding of how risks should be managed to follow these standards is extremely important for anyone involved in medical software development.

During this in-person course, you’ll gain an understanding of risk management principles, tools and techniques. You’ll learn how to apply the risk management process in practice and receive guidance and insight from quality and regulatory professionals.  The workshop will focus on software devices, however the techniques covered may be applied to hardware devices or components.

This one-day workshop is brought to you by the WEISS Quality Service in collaboration with Psephos Biomedica, a medical device regulatory, clinical, and quality consultancy with extensive experience bringing medical technologies to market.

THE COURSE AIMS & CONTENT

The course aims to help you:

• Understand risk management terminology.
• Understand the need for a risk management system and the importance of risk management planning.
• Employ human factor methods to identify areas of concern in the early design phases.
• Improve your confidence in applying different techniques to identify potential hazards.
• Estimate and evaluate risk.
• Identify and verify risk control measures.
• Understand how to conduct a risk-benefit analysis and review risk management activities.
• Ensure the devices you develop are safe and effective.
• Gain practical skills that can be applied when developing medical software and more widely when developing other types of medical technology.

WHO SHOULD ATTEND?

The course is designed for individuals from any discipline that are working on the design and development of medical device software or health software applications. The course is relevant to research projects aiming to conduct a first-in-human clinical investigation through to translational projects aiming to launch their products on the market.  

The course has also been designed carefully to meet the needs of those who are: -

• new to the risk management process.
• unsure how to apply requirements from the standards in practice.
• looking to improve the design of their device or application.

STRUCTURE, TEACHING & CERTIFICATION

This course is an in-person interactive workshop.  Active participation from attendees is expected.

You’ll learn about the risk management process, the importance of risk management planning, and the different activities that are performed throughout the product life cycle.

The principles and practice of risk management will be explained using real-world case studies to demonstrate a range of techniques that may be used to support hazard analysis and risk management activities. 

Working in small groups, you’ll get to practice these techniques and participate in the identification and analysis of hazards.  These practical hands-on sessions will improve your confidence in risk management activities and enable you to adopt the techniques learnt in your own projects, improving the safety and design of your device or application.

A certificate of attendance will be issued for those who attend the whole day.

COSTS & CONCESSIONS

The full cost of this course is £80. A reduced rate is available for:

• WEISS Quality Service Clients: £40*
• PhD students: £40*

*Please contact the event organiser, Rachael Rodell, for a discount code: r.rodell.12@ucl.ac.uk

(This workshop is run on a not-for-profit basis; all income from course fees will be used to cover costs associated with the event and to maintain and enhance the UCL/WEISS Centre Medical Device Quality Service).

Psephos Biomedica

Psephos Biomedica is a medical device regulatory, clinical and quality consultancy. Founded in 2001, they have worked for over 20 years with clients from around the world to bring medical technologies to market. ​

With offices in Brighton, UK, Galway, Ireland and Bülach, Switzerland, they are a highly focused, experienced team that works with all classes of devices from Class I to Class III, covering areas such as Digital Health and AI, Cardiovascular, Neurovascular, Surgical and IVDs.

LEARNING OUTCOMES

By the end of the course, you should be able to:

• Explain key terms used in the risk management process.
• Clearly describe the importance of risk management planning.
• Explain the risk management process in relation to the product lifecycle.
• Demonstrate the use of different hazard analysis techniques.
• Generate a hazard traceability matrix.
• Conduct a simple risk-benefit analysis.
• Use post-market surveillance data to update and review risk assessment.