ISO 13485
ISO 13485 helps the medical device manufacturers implement an effective quality system.

ISO 13485 for Medical Device Industry

ISO 13485:2003 is a quality management system standard for the medical device industry

It is based on ISO 9001:2000 standard and assumes the same structure, although, certain requirements are specific to medical device industry. The differences between ISO 9001:2000 and ISO 13485:2003 are listed as Appendix to the ISO 13485:2003 standard.

Emphasis of this standard is given to regulatory compliance.

We provide following services to help you through ISO 13485 registration:

A. Development and Implementation Assistance (specialized in Class I and Class II devices)

B. Auditing and audit reporting

C. Training to ISO 13485 standard requirements