Mirmex DC motors & windings for medical applications are now compliant with ISO13485 and FDA 21 CFR 820.
In order to better support the customers who trust Mirmex for providing motors for surgical power tools, surgical robots, motorized prosthetic actuators, miniature medical pumps… we are happy to announce that we are now an ISO13485 certified motor company.
This is an important aspect that also applies to our autoclavable motor winding product range.
In a nutshell, ISO13485 is a Quality Management System somewhat equivalent to ISO9001 but for medical devices. It includes specific medical regulations that medical micromotors manufacturers must follow to ensure no risk is taken with the safety of the products.
Furthermore, it is an important step for providing medical micromotors to the USA that are compliant with the FDA 21 CFR 820 regulations.