Medical device risk management – a holistic approach

Dr Gurge Phull, Medical Regulatory Affairs Manager at Element Materials Technology, will be giving a presentation on: ‘Medical device risk management – a holistic approach.’

Element has laboratories worldwide and testing provide services to the Aircraft, Oil, Railway, Automotive, MOD and Medical industry. Dr Phull’s team provides advice and resources to companies for worldwide medical device regulatory compliance. He has:

- over twenty years’ experience in the pharmaceutical industry (covering R&D, clinical and registrations); – worked with IVD’s (HIV, Hep C, etc), pathology instrumentation and training (customer/sales /service) for more than a decade; – has more than 17 years’ experience working with medical devices.

As main lead / head of quality assurance / regulatory affairs in the UK and abroad, Dr Phull has experience and expertise:

- in product design & development (inception to market launch), manufacturing, training; – auditing quality / regulatory systems for worldwide compliance (EU, USA, ROW – CE marking (MDD), FDA’s QSR, ISO 13485 etc); – standards and testing compliance.