Richard will be sharing his experience by defining what it takes to gain Regulatory Compliance for MD’s, IVD’s and Stand-Alone MD Software (SaMD).

Questions answered during the Regulatory Clinic include:

•  Is my innovation a Medical Device?

• How do I classify a MD, IVD, SaMD, Digital Technology, Telemedicine etc?

• What is a typical roadmap to Regulatory Compliance?

• What is ISO 13485 and how do I get certified?

• What is meant by Design Control and how does this relate to TRL’s (Technology Readiness Levels)?

Following a 45 minute presentation Richard will throw questions out to the floor. Those who may have further questions about their product and situation can arrange a 1-2-1 session after the event with Richard to discuss their specific device or technology. Richard will be on-site from 1pm in Radnor Atrium if you want to pop along to see him or you can book a specific appointment by using his on-line calendar from this link.

This Workshop is supported by the Alderley Park Accelerator Team and the Alderley Park Accelerator: Life Sciences Support Programme