ISO13485 is an internationally recognised quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices. It provides a proven global guideline for maintaining assurance and managing risk.
SingHealth Medical Technology Office (MTO) has successfully set up an ISO13485 QMS to manage design and development projects in accordance with the standard’s requirements. MTO completed the ISO13485 audit in October 2018.
For clinicians who aim to commercialise their medtech innovations, MTO offers ISO13485-compliant quality management services. This ensures that the design and development process is of sufficient quality with proper design history documentation to facilitate clinical trial approvals, regulatory requirements and comprehensive knowledge transfer to our licensees, commercialisation partners and/or start up companies.