Medical Device Quality Management Systems and FDA Regulations
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.
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: