Valuable checklist also available to assist with compliance to this standard.
Specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
- Published:
- 05/01/2019
- ISBN(s):
- 9781570207181
- ANSI:
- ANSI Approved
- Number of Pages:
- 49
- File Size:
- 1 file , 720 KB
- Note:
- This product is unavailable in Ukraine, Russia, Belarus
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