Get the free 15197:2013 In vitro diagnostic test systems Requirements for
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What is 15197 in vitro diagnostic?
15197 in vitro diagnostic refers to a specific regulation that sets requirements for the manufacturers of in vitro diagnostic medical devices.
Who is required to file 15197 in vitro diagnostic?
Manufacturers of in vitro diagnostic medical devices are required to file 15197 according to the regulation.
How to fill out 15197 in vitro diagnostic?
To fill out 15197, manufacturers need to provide detailed information about the in vitro diagnostic medical device, including performance characteristics and safety data.
What is the purpose of 15197 in vitro diagnostic?
The purpose of 15197 is to ensure the quality, safety, and performance of in vitro diagnostic medical devices in the market.
What information must be reported on 15197 in vitro diagnostic?
Manufacturers must report information about the design, performance evaluation, labeling, and post-market surveillance of the in vitro diagnostic medical device on 15197.
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