What are QSRs?
Quality System Regulations (also known as QSRs or Current Good Manufacturing Practices [cGMPs]) are required by the FDA to ensure that manufacturers of medical devices employ high-quality systems to design and manufacture products that are to be marketed in the United States.
QSRs cover management and organization, device design, buildings, equipment, purchase and handling of components, production and process controls, packaging and labeling control, device evaluation, distribution, installation, complaint handling, servicing and records.
What do I need to do to comply with QSRs?
QSR regulations do not describe in detail how a manufacturer must produce a specific device. The FDA only provides the framework that manufacturers must follow – requiring that manufacturers develop and follow procedures and fill in the details that are appropriate according to current state-of-the-art manufacturing for that specific device.
It is the responsibility of each manufacturer to establish requirements that will result in devices that are safe and effective, and to establish methods and procedures to design, produce and distribute devices that meet the quality system requirements.
How can Regulatory Specialists help me with QSR compliance?
Regulatory Specialists, Inc. has years of experience helping companies institute QSR systems. We also provide the invaluable assistance of auditing our clients before an FDA inspection and directly supporting companies with the FDA inspections.