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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 |
