Medical Devices Iso Certifications

We are offering Medical Devices ISO Certifications to our valued customers. ISO 13485:2003 represents the requirements for a comprehensive management system for the design and manufacture of medical devices. All requirements of this International Standard are specific to organizations providing medical devices, regardless of the type or size of the organization. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (1996). ISO 13485:2003 is a quality system standard designed specifically for medical device companies. The standard is applied by most Class II and III (plus Class IV in Canada) medical device manufacturers to meet the quality system requirements of Europe, Canada, Australia, Japan and other parts of the world.