Quality Management System
for Medical Devices
Perhaps more than any other product, medical devices’ quality directly impacts their effectiveness and the patient, users, and other people’s safety. Therefore, most national regulatory bodies require medical device manufacturers and suppliers to have an internal quality management system that is independently verified and audited.
Ortoma´s Quality Management System is ISO 13485 certified. The standard specifies requirements for a quality management system of a medical device manufacturer and includes specific requirements concerning e.g. development, production, marketing, distribution, and sale of medical devices. ISO 13485 is similar in scope and intent to ISO 9001 and includes additional requirements specific to medical devices.
Ortoma´s quality management system is also audited and certified as part of the CE certification of Ortoma´s products and is in compliance with applicable requirements in the U.S. 21 CFR820 (QSR) concerning quality management system.