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- Medical Devices QMS
- Process
- Device history review
Device history review
A device history review gives a lot package an operational context. The lot and device identifier name the subject. The linked inspection identifies the quality case the package supports. The review date and attachment complete the evidence presented to the quality team.
Step by step
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Select inspection Inspector
Inspector chooses the operational inspection that the device history package supports.
- Connects the package to the quality case
- Updates Device history reviews, Inspections
-
Identify device scope Inspector
Inspector records the device lot and identifier against that inspection.
-
Attach package Inspector
Inspector adds the record package and reviewed date.
-
Submit review Quality Reviewer
The submission is checked against the operational record, lot, identifier, package and date.
-
Complete review Quality Reviewer
An incomplete case is finished before the review reaches Approved.
Who does what
Roles and permissions- Inspector
- Submits the case.
- Quality Reviewer
- Examines the package in the context of the linked inspection.
- Admin
- Controls access.
Set up Medical Devices QMS your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.