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This document adopts ISO 14971:2019, which specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
Product Details
- Edition:
- 1st
- Published:
- 06/26/2020
- ISBN(s):
- 9781760729141
- Number of Pages:
- 37
- File Size:
- 1 file , 2.3 MB
- Product Code(s):
- 10184366, 10184367, 10184368