Medical Devices Mfg
Medical Devices Mfg: production orders and BOM, stock and warehouse, quality and reporting.
Challenges
- Device serial/UDI records are not linked to sales, so no recipient can be identified for a field safety notice.
- Technical files and risk records sit in scattered folders, so audit preparation takes days.
- Sterile and non-sterile batches appear in the same stock, creating a risk of wrong shipments.
- Complaint and corrective action records stay in e-mail, so closure time cannot be measured.
Workflows
From production to batch release
- The production order opens with a revision-controlled bill of materials and a batch number.
- In-process checks and the sterilisation record are posted to the batch file.
- The batch is held in quarantine stock until quality approval is granted.
From sale to field follow-up
- At shipment the serial/UDI number is matched to the customer and the invoice.
- When a complaint arrives, the related batch and customer list is produced.
- A corrective action is opened, and its closure and effectiveness are recorded.
Documents
- Batch production and sterilisation record
- Technical file and risk management document
- Serial/UDI shipment list
- Complaint and corrective action form
Reports
- Batch-level traceability breakdown
- Quarantine and release status
- Complaint closure time
- Shipped serial list by customer
Metrics
- Batch release lead time
- Complaint closure time
- Batch rejection rate
- Traceability completeness rate
Compliance
- Medical Device Regulation (MDR) and CE certification
- ISO 13485 quality management system records
- UDI registration and field safety notice obligation
Glossary
- UDI / serial number
- The stock and shipment record that identifies each device uniquely
- Quarantine stock
- A stock status closed to sales while awaiting quality approval
- Batch release
- The quality approval step that makes a batch sellable
- Corrective action
- A task opened from a complaint together with its closure record
Frequently Asked Questions
Can I find which serial went to which customer?
Yes — the serial/UDI number is linked to the invoice at shipment, so a customer-level list can be produced.
Can I keep the technical file together with the product?
Yes — the technical file and risk records are stored in the item card's document archive.
Can I stop an unapproved batch from being sold?
Yes — while a batch is in quarantine it is blocked for shipment and opens only after release.
Can I follow the complaint process?
Yes — the complaint record is linked to a corrective action task and closure time is reported.
Can I narrow the scope of a recall?
Yes — because the raw material–batch–shipment chain is traced, only the affected serials are blocked.
