Medical Devices

We can help you meet your regulatory and quality requirements for medical devices.

Medical devices

We provide rigorous quality management reviews and product certifications for medical device manufacturers around the world, and we can do it for you too.

Find out more about our medical device services >

Medical device quality management certification

Medical device training courses

CE Marking of Medical Devices training >

Understand the legal and operational aspects of European CE Marking in line with the European Medical Devices Directive (MDD)
Increase EU market access and boost customer confidence

View details for CE Marking of Medical Devices training >

€1350

3 day classroom training course

View all of our available medical device training courses

Popular medical device standards

BS EN ISO 14155:2011 >
Clinical investigation of medical devices for human subjects. Good clinical practice

Published Date: February 2011
BS EN 80001-1:2011 >
Application of risk management for IT-networks incorporating medical devices. Roles, responsibilities and activities

Published Date: April 2011
BS ISO 15223-2:2010 >
Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Symbol development, selection and validation

Published Date: June 2010

Find more medical device standards in the BSI Shop >

Medical devices

Medical devices

Medical devices

Medical device quality management certification

ISO 13485 Quality Management for Medical Devices

Medical device training courses

CE Marking of Medical Devices training >