Paul Brooks
Medical Devices
RAPS
Australia
Biography
Paul Brooks has more than 25 years of work experience within the medical device regulatory affairs environment during his 35-year career 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 responsible for review and clearance of medical devices against European regulations. He also led BSI in achieving formal recognition as a recognized third party under FDA’s Center for Devices and Radiological Health (CDRH) and Health Canada’s Canadian Medical Devices Conformity Assessment System (CMDCAS) programs, and he is known both domestically and internationally as an expert on medical device regulations and regulatory issues.
Research Interest
Medical Devices
