Medical Devices | GMPs/QSRs
Most medical devices must be manufactured in accordance with FDA’s 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 FDA’s GMP regulations to the more internationally recognized International Standards Organization (ISO) process. However, in contrast to ISO, the FDA QSRs emphasize medical device design control procedures and device design history.
To some degree, this distinction arises from the fact that FDA has separate approval or clearance processes that relate to device safety and efficacy. QSRs, therefore, aim to ensure that the manufacturing process can continuously produce the device marketed device. Important aspects of the regulations are design control, corrective and preventative actions, and document controls.
FDAImports.com, LLC can bring to your manufacturing process former FDA medical device facility inspectors and compliance officers who can evaluate your standard operating procedure, quality polices, and manufacturing records to ensure compliance with FDA’s QSRs.