ISO 1385 Posts

The Increasing Need for Quality Medical Devices is Matched by the Need for Compliance with ISO 13485:2003

In October 2010, Medtronic agreed to pay $268 million to settle U.S. lawsuits and claims related to its Sprint Fidelis family of defibrillation leads recalled three years ago due to faulty wires. In 2009, the company estimated that at least 13 people may have died because of the problem. It’s situations such as this that emphasizes why standards have been put in place, such as ISO 13485: 2003, that help medical device companies maintain quality assurance and manage risk. (more…)