Requirements checklist
What to ask for when choosing software for medical device manufacturers.
A checklist built from how medical device manufacturers work, to print or save as a PDF and bring to any supplier meeting.
What the software should cover
Tick each one that matters to your business.
- Bills of materials and revisions
- Production orders and routings
- Lot and serial traceability
- Inspection and release
- Complaints and corrective actions
- Supplier approval and outside processing
Roles that need their own access
Who logs in, and what each person may see or change.
- For owners and plant heads
- For quality and regulatory teams
- For production planners
- For operators and technicians
- For purchasing and stores
Reports to ask for
Ask to see each one with your own sample data.
- Lot trace from finished device to component lots and shipments
- Production orders by status, machine and due date
- Inspection results and failures by part and supplier
- Complaints by device, cause and closure status
- Corrective actions open, overdue and closed
- Supplier approval status and certificate expiry
- Stock of components and finished goods by location
Systems it may need to connect to
Note which ones you already run.
- SMS
- WhatsApp and other messaging
- Barcode and label printers
- Accounting software export
- Spreadsheet import
Questions for any vendor
Put these to every supplier you are comparing.
- Does it follow one particular quality standard?
- Can a device be traced back to its component lots?
- Can it handle serial numbers as well as lot numbers?
- How are complaints linked to corrective actions?
- What happens when a bill of materials changes?
- Can parts sent for sterilisation or coating be followed?
- Can we bring in our existing part and supplier lists?
- Do operators need a computer at each machine?
- Who owns our production records?
- How is pricing worked out?
Where the work usually breaks today
Circle the ones you recognise. They set the order of the project.
- Trace records live in separate files
- Old revisions stay in circulation
- Inspection forms are filed away from the lot
- Complaints and actions are tracked apart
- Supplier approval lapses unnoticed
Prefer to talk it through? See the medical device manufacturers page.