Medical Devices: Navigating the Evolving Landscape

Speakers

Details of our speakers can be found below:

Steve Lee

Steve is a Director of Diagnostics Regulation at ABHI. After completing his degree in Biochemistry and Biology at Aston University, Steve trained as a Biomedical Scientist, working in hospital microbiology before moving to industry to work as a company microbiologist. Steve joined MHRA in 1996 when it was still the Medical Devices Agency and when the IVD Directive had yet to be implemented. While at MHRA, Steve worked with manufacturers, Notified Bodies, other Competent Authorities, Trade Associations, standards bodies and government departments. Steve was Chair of the European Commission’s IVD working group when the IVD regulations where being developed. In 2019, Steve was presented with the TOPRA award for regulatory excellence.

Claire Burrows 

Claire is a Partner at Brabners in our regulatory and professional conduct team. A specialist regulatory compliance lawyer with expertise in health and safety, product safety and medical device regulation, Claire is often involved in complex regulatory investigations. Claire has advised many clients on the complexities of medical devices on the market to ensure that they meet specific regulatory requirements. She advises clients on their specific legal obligations in respect of health and safety considerations, conformity testing and certification, technical file and labelling requirements. This allows clients to ensure that fully compliant products are placed onto the UK market and regulatory liability is effectively managed in complex supply chains. Claire also supports clients in ensuring they achieve on-going regulatory compliance, managing interactions with the regulator, third parties and end users on behalf of her clients when required.  

Joseph Burt

Joseph is an experienced Quality and Regulatory professional who is enthusiastic about delivering innovative, safe and pioneering medical devices to the benefit of patients and for use by healthcare practitioners. With over 25 years of experience working in small to global medical device companies, he has developed several in vitro diagnostic medical devices, including the approval of developed devices with multiple jurisdictions. He is passionate about bringing positive outcomes through the use of innovative medical technologies and a champion for early diagnosis for preventative healthcare. Joseph is the Head of IVD and General Medical Devices with the MHRA.

Clare Thompson

Clare Thompson is an accomplished Devices Regulatory Specialist with a PhD in cell biology and over ten years of experience in bioengineering research. Throughout her career, Clare has excelled in various roles, including scientific research, managing a core facility for drug discovery technologies and leading policy development. Driven by a desire to play a pivotal role in advancing medical technology and contributing positively to society, she transitioned into the field of medical device regulation. In her current position at the Medicines and Healthcare products Regulatory Agency (MHRA), Clare has successfully overseen the implementation of new legislation aimed at enhancing post-market surveillance of medical devices. Her dedication and leadership have been vital in driving strategic priorities and delivering improvements for patient safety.

Dr Iain Charlton CEng

Iain has worked in medical device and healthcare software for over 25 years, with experience across research, software development and QA/RA. He specialises in the regulation of SaMD, with particular interest in software development, AI, privacy and cybersecurity. He works with many early-stage health technology startups to develop regulatory strategies for new products and prepare clearances for the UK, EU and US markets. He also holds a voluntary position on the board of the Biomedical Engineering Division at the IMechE. Iain's session will focus on navigating the changing landscape of healthtech regulations.