Practical Risk Management for Software Devices

OVERVIEW

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.

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.

Concessions