ISO 13485

ISO 13485 is a quality management system standard designed specifically for medical device manufacturers.


A Quality Management System compliant with the standard is mandatory for a number of classes of medical devices in Europe and Canada.

The ISO 13485:2003 is based on ISO 9001:2000 standard, and has many of the same requirements. However, there are additional requirements for design control,process control, retention of records, traceability, compliance with regulatory requirements and others. 

mi-CE consultancy is specialized for assisting you to comply to the ISO 13485:2003 requirements.


Additional, due to the specific qualifications of our consultants, we can offer full compliance to comply to the QMS requirements of the Canadian Regulations as well. The consultant is qualified to execute audits ISO 13485:2003 under CMDCAS.


In detail CANADA:

Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars. The Medical Devices Regulations do not require importers or distributors of medical devices to have a registered quality system.

The Medical Devices Regulations require class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485:2003. There are no regulatory quality system requirements for Class I medical devices. These quality system requirements came into force on January 1, 2003.

A link to the Medical Device Aactive Licence List (MDALL) site of Health Canada is located here.