Please note this workshop is an exclusive in-person training. If you are interested in joining, please email us at spark-uk@aston.ac.uk.

Poorly planned and executed clinical evaluations of medical devices is the number 1 reason for medical devices failing to achieve UKCA and CE marking. Notified bodies require a robust and scientific approach to clinical evaluations based on the current state of the art with sufficient evidence for the device under evaluation. 

The following workshop will provide participants with the following skills and education to help them prepare for the notified body assessment: 

• How to adequately conduct a state-of-the-art assessment and develop objectives and endpoints for the clinical evaluation. 

• Understanding the sufficient evidence requirements for the device under evaluation. 

• Claiming equivalence and the common pitfalls of the approach. 

• Expectations on clinical investigation design for conformity assessment process

• Post Market Clinical Follow Up – Its scientific purpose and the requirements to conduct these activities. 

This showcase is sponsored through Aston University’s active involvement with the West Midlands Health Tech Innovation Accelerator (WMTHIA). The WMHTIA is funded by the Department for Science, Innovation and Technology, in partnership with the West Midlands Combined Authority and Innovate UK.