Paul Brooks

Headshot of Paul Brooks
Title:
Senior Vice President, Healthcare Solutions, BSI America

Paul qualified with BSI as an electro-mechanical technician engineer and progressed to a Senior Certification Officer responsible for certification of products and registration of quality management systems to BS 5750 (UK predecessor of ISO 9000).

In 1993 Paul joined BSI’s US subsidiary and work as the local expert on CE Marking under the Medical Devices Directive. During his 6 years with BSI Inc Paul worked with over 400 US medical device manufacturers that were selecting a notified body and beginning the CE Marking process for complying with European regulations. He also led on programs to raise awareness of the new European CE Marking regulatory approach in North America.

In 1998 Paul return to London to be Head of Notified Body for BSI’s Medical Devices Group, and was regularly involved in European Medical Devices Notified Bodies meetings and technical groups, interacting with UK Competent Authority, trade / industry groups and in Brussels at Notified Body meetings with the European Commission.

Paul relocated back to BSI’s Washington DC office in 2001 and is now responsible for leading BSI activities in the medical devices regulatory sector for the Americas region including EU Notified Body, ISO 13485 Certification, Health Canada / SCC CMDCAS accreditation and MDSAP Auditing Organization recognition.

Paul is a long standing member of the Regulatory Affairs Professional Society (RAPS), serving as a Board member for six years and 2013 Chairman, he is also a long-term member of American Society for Quality (ASQ) – Biomedical Division and routinely presents and trains at sessions organized by both of these societies as well as other sector focused meetings/conferences.