Serial no.
Per device.
Industry and segment
Medical device manufacturing: records and traceability, for U.S. teams
We build for how Norwegian small businesses really operate: MVA that changes by county, tax documents contractors, and peak seasons that differ by region. 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.
- English and community languages
- Stripe and NOK
- 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.
Norwegian-specific points
Norwegian 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 inspection plan, measurements and defect records in the U.S.: fixed NOK quote, MVA by county, GDPR-aware.
Learn moreBatches and traceability
Traceability: from raw material batch to customer in the U.S.: fixed NOK quote, MVA by county, GDPR-aware.
Learn moreDocuments and drawings
Documents: drawings, instructions and versions in one place in the U.S.: fixed NOK quote, MVA by county, GDPR-aware.
Learn more