Case Study: Cardiaccs AS achieves 2x faster ISO 13485 certification with Qualio

How to Rock ISO 13485 Cardiaccs Did It 2x Faster with Qualio

Cardiaccs AS, a medtech company spun out of Oslo University Hospital research, struggled with a legacy Quality Management System that was slow, unstable, lacked digital signatures and FDA 21 CFR 820 compliance, and forced remote staff to print and snail-mail documents. To modernize document control and accelerate ISO 13485 certification, Cardiaccs AS evaluated QMS vendors and selected Qualio’s cloud-based quality management system.

Qualio was implemented in days, delivering native document workflows, web-based review/approval, digital signatures, training and CAPA workflows, enabling Cardiaccs AS to establish design and document control quickly. The result: Cardiaccs switched to Qualio in May 2015 and achieved ISO 13485 certification six months later (a 50% reduction in certification time) with no added quality staff; remote audits that once required weeks were completed in hours, improving collaboration and readiness for CE marking.

Cardiaccs AS

Jonas Tyssø

Project and Quality Manager