ISO Certification

The International Organisation for Standardisation (ISO) is an international-standard-setting body composed of representatives from various national standards organisations. Founded in 1947, the organisation declares worldwide proprietary industrial and commercial standards

MAC Surgical is fully compliant with ISO 13485 and has achieved full certification.  Find out more about what this means below.

ISO 13485

MAC Surgical is fully compliant with ISO 13485 standards and has gained full certification. ISO 13485 was published in 2003 and represents the requirements for a comprehensive management system for the design and manufacture of medical devices.

Various state and federal health and medical authorities have moved or are moving toward compulsory adherence to ISO 13485 for the repair and maintenance of surgical equipment.

MAC Surgical’s compliance details are as follows:

BSI  ISO 13485:2003
Cert. No: MD 555324
Scope: Design, manufacture and repair surgical instruments