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- Medical Devices QMS
- Who it's for
- Device manufacturers
Device manufacturers
A device manufacturer needs to see what was checked on a lot, which evidence was reviewed and what happened when a requirement failed. The quality team can organize in-process and final inspections by subject reference and type, keep each requirement result as a linked check, and place a device history package beside the operational inspection.
How Medical Devices QMS is set up for you
Production quality
Assign an Inspector to an in-process case, capture observations and attachments on each check, and send the inspection to the Quality Reviewer.
Lot evidence
Record the device lot and identifier in a device history review with its package and the inspection it supports.
Failed scope
Link a rejected inspection to a nonconformance so the owner can investigate and carry out a corrective action.
Staff instructions
Keep the controlled work instruction version and the people who acknowledged it available for review.
A device manufacturer needs to see what was checked on a lot, which evidence was reviewed and what happened when a requirement failed. The quality team can organize in-process and final inspections by subject reference and type, keep each requirement result as a linked check, and place a device history package beside the operational inspection.
Start with one product or device family and a representative final inspection. Use a subject reference the production and quality teams recognize. Attach only the checks required for that case, with a passing and a failed example. The reviewer should be able to open the check evidence before deciding the inspection. For the failed example, follow the resulting nonconformance into its corrective action and effectiveness review.
Add a device history review for the same operational case. Compare the lot and identifier with the attached package before submission. An incomplete package should be resolved in the review record. The team can then agree how it names the package and links it to the inspection used for disposition.
If the first cycle includes a revised work instruction, let the Document Controller enter the controlled version and an acknowledgment for the Inspector. That gives the team a concrete way to check that the person performing the inspection can find the right instruction.
Features to start with
Inspections
Follow incoming, in-process, final and service inspections from assignment through reviewer disposition.
Nonconformances and corrective actions
Keep failed inspection scope, containment, root cause and effectiveness review connected.
Device history reviews
Review a device lot's record package against the inspection that identifies its operational scope.
Roles on the team
- Inspector
- Performs assigned inspections and submits their evidence.
- Quality Reviewer
- Decides inspection disposition and checks corrective action effectiveness.
- Corrective Action Owner
- Investigates failed scope and carries out the assigned action.
Set up Medical Devices QMS your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.