How do you review and approve a change to a User Manual?
Автор: Medical Device Academy
Загружено: 2022-01-21
Просмотров: 1052
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Even though your User Manual is a document, you should not be using your document control process to review and approve a User Manual. The User Manual is also the Instructions for Use (IFU) for your device, and the specifications are design outputs. Therefore, you need to follow design change control procedures for the review and approval of an IFU.
This live streaming video explains more about how to control this process and what things you need to consider.
Registration Link for a webinar on "How to write Instructions for Use (IFU)" - https://medicaldeviceacademy.com/how-...
Registration Link for "Design Changes Webinar" - https://medicaldeviceacademy.com/desi...
Link for purchasing Change Control Procedure (SYS-006) - https://medicaldeviceacademy.com/chan...
Link for purchasing Labeling & Translation Procedure (SYS-030) - https://medicaldeviceacademy.com/labe...
The labeling & translation procedure will be split into two separate procedures later in February 2022:
SYS-030 Labeling Procedure - https://medicaldeviceacademy.com/labe...
SYS-052 Translation Procedure - https://medicaldeviceacademy.com/tran...
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