OUR PEOPLE

Bernard Sweeney

Bernard has over 25 years’ experience in the medical device industry. He has a wide commercial, R&D and regulatory affairs background in international markets, gained from working with Becton Dickinson Ltd, Beiersdorf AG, Huntleigh Technology Inc. and Femcare Nikomed Ltd. Also recently as the Managing Director of the British Standards Institute (BSi) Healthcare Division, which included the Notified Body.

During this period he set up operations in the USA and Asia for the division and has been actively working with a number of Asian regulatory bodies including India, China, Hong Kong and Malaysia to assist in introducing new regulations. Bernard is considered to be an expert on global regulations with an emphasis on Asia and has the background necessary to assist in developing a strategic approach to product launches within the new regulatory environment.

Andrew Morley

Andrew has an extensive background in complex operations and project management with 18yrs experience working in Greater China. His previous role as Vice President in BSI (British Standards Institute) Product Services involved a major focus on medical devices and supporting market access services to major MNCs for higher risk devices. These included Johnson & Johnson, Medtronic and Boston Scientific.

As a senior manager and as a consultant Andrew has specialist experience of complex cross cultural project management, working closely with different markets and ensuring effective communications resulting in products meeting required quality, cost and delivery.

Rod Ruston

Rod specialises in providing business and regulatory services to organisations that are involved in medical devices and in vitro diagnostics, whether it be research, design, manufacturing, marketing or distribution.

Rod has been working with companies developing, designing, marketing or distributing medical devices for over 10 years. During that time they have worked with one person start-ups to global healthcare manufacturers.

For start-ups this means helping to create all aspects of business operations including business strategy, marketing strategy, finance, human resources, health and safety and integrating that with regulatory affairs and quality assurance. For larger companies this often means reducing incomprehensibly complicated systems into usable roadmaps to the marketplace.

James Pink

James has 12 years’ experience in the medical devices industry. He has extensive experience of auditing medical device manufacturers as a medical device lead auditor with the British Standards Institute. James is considered as an expert in medical device quality and risk management having undertaken extensive research relating to the modes of failure and their controls within high risk medical devices.

James has held senior technical management positions, notably as engineering and regulatory affairs director for Symmetry Medical Inc. where he was responsible for engineering and quality teams providing design and manufacturing solutions to the orthopaedic, cardiovascular and dental sectors.