Serial no.
Per device.
Industry and segment
Medical device manufacturing: records and traceability
Medical device manufacturers are expected to keep orderly and complete records. The system links batch and serial numbers, document versions and inspection records; who changed what and when can be traced.
- German, French, Italian, English
- QR-bill and CHF
- Roles and audit log
Traceability
Each device is recorded with its serial number, the part batches used and inspection results. If a problem occurs in a batch, the affected devices are listed in a few steps.
This is not a quality-management certification or a declaration of regulatory conformity.
Documents and changes
Versions of instructions and procedures are stored and only an authorised person changes them. Every change is written to the audit log with old and new value.
For regulatory requirements, the quality officer or a specialist is consulted.
How we work
- 1
Clarify the need
By e-mail we discuss your processes, roles, existing systems and how data is moved, and set the scope in writing.
- 2
Build and connect
We build the solution around your workflow and connect it to e-mail, calendar, documents and payment.
- 3
Test and launch
We test every flow with realistic cases, train your team and go live only when it is right.
Swiss-specific points
Swiss medical device makers face strict regulatory and customer expectations. The software helps keep records orderly; regulatory interpretation, certification and conformity declarations remain the responsibility of the company and specialists.
Frequently asked questions
Does it ensure regulatory compliance?
No; it helps keep records, responsibility for compliance lies with the company and is clarified with a specialist.
Can serial number labels be printed?
Yes; label format and printer are clarified at project start.
Related topics
Quality control
Quality control: inspection plans, measurement records, defect and reject records, corrective actions and reports. Quote by e-mail.
Learn moreBatches and traceability
Batch and traceability: forward and backward tracing from raw material batch to finished product and customer, searching affected batches. Quote by e-mail.
Learn moreDocuments and drawings
Document management in manufacturing: drawings, work instructions, measurement reports, versions and access. For Swiss manufacturers. Quote by e-mail.
Learn more