Medical Devices & Services

There is probably no other industry where the importance of product conformity is as crucial as that in the design and manufacture of medical devices. Standards in any industry are an important way both to safeguard product conformity while simultaneously harmonizing requirements, not only nationally, but internationally as well.

An important step in safeguarding product conformity and ensuring that a manufacturing or design process can consistently produce product of the required standard, is a structured management system.

NQA has significant expertise in the medical device manufacturing sector and is ideally placed to assist clients to successfully implement ISO 13485 and supporting standards. Our clients in the medical sector include New England Biolabs, Pac-Dent International, GESUS New England, Tecomet, and RR Donnelley Banta Global.


For further information, please click on the links to applicable standards below.

ISO 13485 Quality management system for medical device manufacturers

ISO 9001:2008 Quality Management System Standard (QMS)

ISO 14001 Environmental Management System Standard (EMS)

OHSAS 18001 Occupational Health and Safety management system standard.