Barry Carter

Head of Quality & Regulatory Affairs

Barry Carter

Head of Quality & Regulatory Affairs

Barry Carter is a Quality & Regulatory Affairs professional with over 20 years experience in medical devices that has a positive proven track record of implementing quality management systems and successfully getting innovative medical device products into the global marketplace.

Barry qualified as a post-graduate with a MSc in Manufacturing: Management and Technology and moved into medical electronics where he has steered many companies through compliance with the Medical Devices Directive.

He has set up and gained accreditation for quality management systems to ISO 9001 and ISO 13485 at facilities around the world and had global responsibilities for achieving the CE mark on a diverse range of medical device technologies and classifications (Class I-III) including a range of electrocardiographic (ECG) recorders and analysers, event recorders, respirometers and peak-flow meters, anaesthesia systems, ambulatory blood-pressure (ABP), a robotic laparoscopic camera holder and blood gas analyser.

In addition, he has obtained a number US FDA 510(k) market clearances and successfully hosted FDA inspections in the UK and USA.  Other achievements have been to obtain numerous device licences including those for Canada, Korea, Kazakhstan, Slovakia, Thailand, Taiwan, Russia, Singapore, Mexico and Peru.

Areas of expertise

Quality ISO 13485
Regulatory CE 510(k)
Medical FDA