Case Study: Nidacon International AB achieves verifiable document management with CANEA ONE

Verifiable system meets high regulatory requirements

The medical device company Nidacon International AB, a Swedish manufacturer for the IVF sector, faced challenges in meeting stringent regulatory document control requirements under ISO 13485:2016. Their manual document management process was becoming unsustainable, leading to deviations during audits. This challenge led them to contact CANEA for a verifiable system.

CANEA implemented its verifiable CANEA ONE system, specifically the document and case management modules. The solution provided Nidacon with a resource-optimizing tool that ensures compliance, making audits easier and giving the entire team confidence that requirements are met. While no specific metrics are given, the result is a secure and efficient system that has eliminated pre-audit checks. Nidacon also praises CANEA's professional support and is considering implementing additional modules.

Nidacon International AB

Magda Holmes

Vice President