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, Canada and soon USA /FDA as well .

The ISO 13485:2016 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 13485:2016 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 able  to execute MDSAP ISO 13485:2016 audits.