A dedicated Compliance Director and Data Protection professional, specialising in Artificially Intelligent Medical Device Software, their Global Regulations, Quality and Data Protection requirements.

An extensive background of with over 20 years experience in the Quality Assurance & Regulatory Affairs space, with extensive knowledge in all Classes of medical device, their Quality Management Systems, global regulations, manufacture, remediation, registrations – from start-ups through to multi-national companies with a global footprint. Over the last few years, successes have included the transference of Notified Body Certificates; successful member of audit team for a range of jurisdictions, clients and products, as well as significant experience as a lead auditor; the reduction of Q&R budgets whilst increasing the skills and abilities of Team Members; parachuting into Companies in periods of change and urgent need; and the restructuring and organisation of Quality Management Systems to boost efficiency and compliance rates. 

Recently, navigating the complex world of Artificial Intelligence in the medical device landscape has led to a particular skill set – in such that whilst there are medical device regulations, QMS knowledge, data protection legislation and AI guidance, they do not form a cohesive picture to allow for the development, implementation and update of either medical devices containing AI or AI as a medical device itself. This area is fast moving in the industry, but a lack of pace by Regulators, Standard Bodies etc, will result in the situation whereby those entities will issue requirements that are generations behind the current state of those devices on the market. Throw into the mix the challenge of data protection needs and the disparate way in which software and medical devices are developed, there is a big space that requires filling.