Case Study: InVivo Bionics achieves a faster, higher-quality route to market with Qualio

How a medical device company doubled their speed to market

InVivo Bionics is a Norwegian medtech company developing a hybrid software/hardware bladder pressure microsensor and targeting EU MDR and ISO 13485 accreditation with CE marking by the end of 2024. The team needed audit trailing and full traceability, a centralized QMS, and control of design controls, CAPAs and customer feedback as they moved toward marketization — so they selected Qualio’s eQMS to embed quality across the organization.

Qualio delivered a single, validated eQMS platform with white‑glove onboarding where staff, consultants and suppliers access harmonized documents, training and design control workflows. The result is a single source of truth, stronger design control management and a culture of quality across the company; measurable impacts include 100% company engagement with Qualio, an estimated 2x (100–200%) faster speed to market and 1x FTE spend mitigated by using Qualio.

InVivo Bionics

Daniel Aragao

Chief Technology Officer