Operation Paperless: Scaling Compliance for Series B

Challenge

A rapidly growing surgical robotics company was drowning in physical binders. Document retrieval was slow, version control was prone to error, and preparing for audits was a multi-week, all-hands-on-deck fire drill that paralyzed the organization.

Solution

Leanabl managed a full-scale digital transformation. We architected and implemented a cloud-based eQMS, migrating over 500 legacy documents from their DHF and QMS. This included executing the complete Computer Software Validation (CSV) package (IQ/OQ/PQ) and retraining the entire 50-person staff on the new digital SOPs.

Outcome

The company passed a surprise ISO 13485 audit with zero major findings just two months after go-live. Document retrieval time was reduced by over 95%, and engineering change orders that previously took weeks are now approved in days.