Triomed stays inspection-ready and ships faster
Triomed builds dialysis technology inside strict regulatory expectations. Compliance can't slow the team down, and it can't slip.
- Industry
- Medical devices, dialysis
- Team
- Regulated team, 4 sites
- Outcome
- Shorter release cycles
- Website
- triomed.se
The challenge
Living inside FDA, ISO 13485, and 21 CFR Part 11 expectations across four sites made every release heavy with sign-off overhead.
The quality team needed to be inspection-ready at any moment, without release cycles grinding to a halt.
How neo helped
neo's closed-loop approval flow routes every change through the configured chain with validated electronic signatures.
Complete audit trails and release dossiers that assemble themselves keep Triomed audit-ready without extra work.
Shorter
release cycles
4 sites
kept in sync
Always
inspection-ready
Our quality team is always inspection ready. neo's closed-loop approval flow has meaningfully cut our release cycles.