This an invite only event. If you are interested and would like to attend please get in touch with us (spark-uk@aston.ac.uk).

We are very fortunate to host this full day interactive session with BSI’s Richard Holborrow, Head of Clinical Compliance, and MHRA’s Head of Clinical Investigations, Mark Grumbridge.

This workshop will focus on the clinical aspects of medical device development and will explore:

• Intended purpose statements

• Clinical benefit claims

• State-of-the-art considerations

• Clinical evidence requirements

• Clinical evaluation planning

• Whether clinical investigations may be needed and, if so, why

• Key questions likely to arise during conformity assessment or clinical investigation submissions

Three SPARK teams will prepare material to facilitate open discussion on these key areas and be used as exemplar case studies.