idsMED Singapore Achieves ISO 13485 Certification

On 5 December 2019, idsMED Singapore achieved ISO 13485, an international Quality Management System (QMS) that sets the standard for the medical devices industry. This achievement came after 8 months of training the various departments including sales, operations, engineering, HR and regulatory on good documentation practices and maintaining high safety standards.

What is ISO 13485?

ISO 13485 is an international standard that sets out requirements for a quality management system (QMS). An organization that is ISO13485 certified has demonstrated its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

What this means for idsMED Singapore?

idsMED Singapore is already certified to GDPMDS, a Singapore-specific, basic requirement for distributors of high-risk medical devices. In addition to the basic GDPMDS requirements, the ISO certification means that idsMED Singapore has also adopted the risk management approach for related processes in our quality management system. Our engineering workshop is also ISO-certified, further acknowledging our commitment to maintaining safety standards.