01
Case study 04 · Medtech · Basel
Audit-ready under ISO 13485.
Major findings
0
Duration
5 mths
Audit preparation
−70%
Records
2,300
02
The situation
A medical-device manufacturer in Basel kept test records, deviations and CAPA measures in Excel lists. Evidence was missing before every audit, and versioning could not be relied on.
The solution
Custom business software for test records, deviations and measures with a complete history and electronic sign-off. Every document is versioned; the audit export is one click.
Result
The recertification audit passed with no major findings. Preparation takes days instead of weeks.
My role
Concept, development, handover and operations — from one pair of hands, no subcontractors.
StackNuxt · PostgreSQL · Docker · Schweizer Hosting
Duration5 mths
03