Preparing for ISO 13485:2016
The International Organization for Standardization (ISO) published the ISO 13485:2016 medical devices quality management systems standard on March 1, 2016. ISO 13485:2016 identifies the requirements for a quality management system (QMS) in which an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet both customer and regulatory requirements.
As ISO 9001 certified company, PT Matahari Leisure demonstrating its commitment to developing and manufacturing a product that meets customer and regulatory requirements through its Quality Management System. To Improve our hospital equipment manufacturing quality, PT Matahari Leisure is committed to adopt and integrate ISO 13485:2016 in our ISO Quality Management system within this year (2017).
Brand-new hospital bed will release in June to supply domestic market. Our hospital bed has been designed to meet IEC-60601-2-52 safety standard, key principle of our bed design are patient safety, clinical needs, durability and easy of use.