Paul Brooks is executive director at the Regulatory Affairs Professionals Society (RAPS). He has more than 25 years' experience within the medical device regulatory affairs environment and during his 35-year career he has worked with the British Standards Institution (BSI), where he served most recently as senior vice president, BSI Americas Healthcare and previously was head of the medical device EU Notified Body. He led BSI in achieving formal recognition as a recognised third party under

the FDA’s Center for Devices and Radiological Health (CDRH) and Health Canada’s Canadian Medical Devices Conformity Assessment System (CMDCAS) programs, and he is widely recognised as an expert on medical device regulations and regulatory issues.