Risk Management of Medical Devices

28 March 2019

Inox,University of Sheffield

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 workshop is to highlight and reflect on risk management principles and practices for medical devices, particularly in the light of the new Medical Devices Regulation regarding in-house and custom-made manufacture.

Relevant considerations are:
1.    identifying the key risk management processes for medical devices;
2.    exploring the connection between risk management processes as detailed in ISO 14971 and quality management systems such as ISO 13485;
3.    relating those processes to regulatory requirements such as the new EU Regulations for medical devices (MDR);
4.    understanding compliance requirements with regard to custom-made medical devices; 
5.    discussing challenges in implementing risk management 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 links between the risk management standard ISO 14971 and the quality management standard ISO 13485
3.    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. 

Workshop Resources 

The draft programme is available here

On-line registration is open. To book your place, click the 'Book Now' button below and then either log in (members and registered users) or register (new users only).    

Workshop registration fees (including refreshments and lunch):
IPEM member £290 
IPEM member trainee £240 
IPEM member technologist £210 
IPEM member student/retired/non-salaried  
Non-member £390 

Registration deadline: 14th March 2019


This workshop will take place at INOX, which is located within the University of Sheffield Student's Union Building, Durham Road, Sheffield. S10 2TG

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

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