Medtronic to Create Internal Registries to Catch Problems Earlier

Medtronic to Ramp-Up Device Inspections (Biloine Young @ OTW) Medtronic, Inc., the world’s largest stand-alone medical device maker, is no longer going to rely on irregular reports from doctors or patients to monitor its medical devices. Instead the company will ramp up its own monitoring of devices after they are implanted in an attempt to catch [...]

FDA Drops Warning Letter on S+N Regarding Manufacturing Practices of Ceramics in Germany

Smith & Nephew Receives FDA Warning (OTW) S+N received a warning letter from the FDA  said the company’s R3 Ceramic Acetabular Systems, manufactured in Tuttlingen, Germany, are not in conformity with the Current Good Manufacturing Practices (CGMP) requirements.

May 18, 2012

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