Medical Devices | GMPs/QSRs

Most medical devices must be manufactured in accordance with FDAs good manufacturing practice (GMP) regulations, now known as the Quality System Regulations (or QSRs). The QSRs represent the GMP program FDA implements for medical devices in the United States, and they are the closest of all of FDAs GMP regulations to the more internationally recognized International Standards Organization (ISO) process. However, in contrast to ISO, the FDA QSRs emphasize the medical device design control procedures and device design history. This is different from most other countries, which focus instead on the device specifications and effectiveness.

To some degree, this distinction arises from the fact that FDA has separate approval or clearance processes that relate to device safety and efficacy (the device pre-market approval process or the pre-market notification or 510(k) substantial equivalence review process). The FDA QSRs, therefore, are set up to ensure that the manufacturing process is capable of producing the device that FDA has cleared or approved. FDA considers the most important aspect of device manufacturing to lie in the medical device design, the design of the manufacturing process to produce the device, and the evaluation of any failure or defect or complaint to determine whether a resulting medical device design modification is necessary to rectify the problem.

FDAImports.com, LLC can bring to your manufacturing process former FDA medical device inspectors and FDA compliance officers who can evaluate your medical device design, history, and manufacturing records and process to ensure compliance with FDAs QSRs.