It can also help medical device manufacturers: The standard aims to make life easier for medical device manufacturers by serving as a central source of these common, generally applicable requirements, allowing each specific product standard or group standard to focus more concisely on the unique requirements for a specific medical device or group of medical devices. It does not specify the means by which the information is to be supplied. It covers the generally applicable requirements for identification and labels on a medical device or accessory and its packaging, the marking of a medical device or accessory, and the accompanying information. It details requirements for the information to be supplied by medical device and medical device accessory manufacturers. Now that document is being replaced by an ISO standard. There’s been a European standard since at least 1998 covering the information that medical device manufacturers should supply with their products. A new international standard now details information requirements for medical devices What’s happened and why?
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