Date: 18 May 2022

Time: 15:00-16:00

Location: Online – Zoom

Title: Regulation of software, AI and apps as a medical device

Who’ll be presenting this webinar?

MHRA-Medicines and Healthcare products Regulatory Agency

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.

Recognised globally as an authority in its field, the agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development.

Guest Speaker:

Hafsa Sirad – technical specialist in the software and AI team at the MHRA

Hafsa is a Senior Medical Device Specialist in the Software, Apps and AI group at MHRA. Hafsa holds an MSc in Biomaterials and Tissue Engineering from the University College London and a BEng in Medical Materials from Queen Mary University.

Francesca Edelmann – technical specialist in the software and AI team at the MHRA

Francesca has a Bsc in biomedical science from the university of Birmingham. She initially worked as an editor for medical journals for 2 years and then moved to the MHRA, where she has worked for almost 6 years. At the MHRA, she has focused on the regulation of many medical device areas, such in vitro diagnostics, vaginal mesh products and now the software, apps and AI team.

About this event:

This session will provide an introduction to how AI and software is regulated, recent changes to the regulations and top tips for companies that are working in this space.

Who should attend this webinar?

This webinar is designed for businesses, researchers, entrepreneurs, clinicians, product designers and support organisations that want insight into the regulatory changes.

What outcomes can you expect from joining us?

What does the MHRA do?

What is software as a medical device (SaMD)?

How is SaMD currently regulated in the UK and EU?

Future planned changes to the regulation of SaMD

Top tips for those developing SaMD