Some OEMs also rely on contracted third-party servicers to meet their own servicing needs and hold these authorized servicers to the same servicing regulations the OEM is required to meet. In addition to servicing their own products, many OEMs also act as third-party servicers to other OEMs and comply with FDA regulations. ![]() This comprehensive set of post-market requirements helps ensure that all servicing done to a medical device is done by properly trained, properly equipped technicians that all work is thoroughly documented and adverse events are reported to the agency. In addition, OEMs and their authorized servicers are subject to numerous other FDA regulations covering reporting of adverse events, recalls, registration with the agency, and many others. OEM servicing programs must follow strict requirements set out in FDA’s Quality System Regulation, which include specific instructions for training, part and component replacement, documentation of servicing activities, and more. Original equipment manufacturers (OEMs) dedicate extensive resources to establishing comprehensive servicing programs to ensure that their devices are properly maintained and continue to meet safety and effectiveness standards as determined by FDA. Answers to frequently asked questions about OEMs and proper servicing of medical devices.
0 Comments
Leave a Reply. |