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Medical device manufacturers have yet another database to worry about, since the FDA launched a website where anyone can file a complaint that a medical device is violating agency rules. Read More
Medtronic warned customers in early October of an issue with some of its Model 37751 rechargers for its deep-brain stimulation devices, saying they may become unresponsive and unable to fully recharge the neurostimulator until they are reset. Read More
Medical device manufacturers need access to quality benchmarking data and related FDA guidance to improve their products, says a new report from the Medical Device Innovation Consortium. Read More
What has always been implicit in the FDA’s Quality System Regulation is spelled out in detail in the 2016 version of international standard ISO 13485. Read More
The FDA’s unique device identification (UDI) rule might improve device tracking but is plagued with unresolved issues such as how to label devices with multiple components. Read More
Sweeping new medical device regulations in the European Union are expected to be finalized in December or early 2017, although medical device manufacturers will still have three to five years to comply. Read More