Risk Management of Medical Devices

28 March 2019


Organised by IPEM's Rehabilitation and Biomechanics Special Interest Group

The development of medical devices, including software, must incorporate comprehensive risk management processes, in order to provide assurance of the product’s reliability and safety for clinical application. 

The aim of this one-day symposium is to highlight and reflect on risk management principles and practices for medical devices.  Relevant considerations are:
1. identifying  the key risk management processes for medical devices 
2. relating those processes to other regulatory requirements such as the new EU Regulations for medical devices (MDR) 
3. exploring the connection between risk management processes as detailed in ISO14971 and quality management systems such as ISO13485
4. understanding compliance requirements with regard to custom-made medical devices
5. discussing challenges in implementing risk manamgement processes in practice 

Learning Outcomes
1. an understanding of risk management processes for medical devices as detailed in ISO 14971 
2. an understanding of the different regulatory requirements regarding risk management of medical devices

Target Audience
Clinical scientists (including STP trainees), rehabilitation and biomedical engineers, medical physicists, managers, academia, and industry. 

On-line registration will open soon. 

Registration deadline: 14th March 2019

Conference Resources 
The provisional programme and abstracts will be available here in due course.
Presentation slides will be available after the event here (IPEM Members only - login required)


This conference will take place in central Sheffield, details to follow. 

If you have any queries, please 
email the IPEM conference team or tel: 01904 550598. 

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