Manufacturers of finished medical devices made or sold in the United States must comply with GMP regulations enforced by the U.S. Food and Drug Administration (FDA). The Quality System Regulation or QSR (21 CFR 820) contains essential requirements that apply to medical device manufacturers, and it is the primary medical device regulation that the FDA enforces. Companies that are in the process of establishing their medical device quality management systems should address specific QSR requirements. The same thing goes for companies planning to use medical device quality management software; they must make sure that the software they choose offers features that comply with QSR requirements.
Apart from FDA regulations, ISO 13485 is perhaps the most widely known quality standard that applies to medical device manufacturers. Just like QSR, ISO 13485 requires the establishment of effective medical device quality management systems.
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Under QSR, medical device manufacturers must establish a quality system (otherwise known as medical device quality management systems) that should cover the following fundamental requirements:
Manufacturers that comply with FDA regulations will find it easier to comply with ISO 13485 and vice versa because the FDA has harmonized QSR with ISO standards, making them complementary. Under ISO 13485, manufacturers must include the following in their medical device quality management systems:
Medical device companies throughout the world use MasterControl quality and compliance software as the platform for their medical device quality management systems. MasterControl is an end-to-end solution that automates and connects all quality processes critical to compliance with FDA regulations, ISO standards, EU directives, and other regulatory requirements.
Using MasterControl as the foundation for your medical device QMS will facilitate your compliance in all critical areas and help you with the following:
Please feel free to contact a MasterControl representative about questions you may have about medical device quality management software systems.