FiberTech Medical is pleased to announce that it has received ISO 13485:2016 certification from ISOQAR for medical device repair services relating to flexible and rigid endoscopes, surgical equipment, and our certified pre-owned endoscopes. This achievement is a significant milestone for FiberTech Medical and further confirms our commitment to provide our customers with safe and reliable repair services for their medical devices.
ISO 13485 is the international standard relating to Quality Management Systems for organizations involved in the manufacture and service of Medical Devices. It embraces FDA’s good manufacturing practices and places emphasis on the use of procedures and documentation to regulate and control how activities and processes should be performed.
ISOQAR is an independent, third-party certification body without affiliation to any other company or organization. It assesses a wide range of manufacturing and service organizations, both throughout the US and across many parts of the world.