Compliance for software according to IEC 62304

Purpose and goal

The project aims to strengthen the organization´s competence through a workshop-based methodology where an external expert guides the company´s key personnel through theoretical training & practical application, to ensure that the company´s medical device software meets the requirements of MDR & IEC 62304.

Expected effects and result

Expected impacts include strengthening the company´s regulatory knowledge, which is a necessary component of the company´s strategic direction forward to reach commercialization. The V&V work which is carried out as part of the project, ensures that the software is both safe and efficient, and thus meets the requirements of IEC 62304, ahead of the upcoming clinical study with a study start in 2026.

Planned approach and implementation

The project will be implemented workshop-based in close collaboration between the hired expert and key people within the company. To ensure knowledge sharing throughout the organization, both the people responsible for Navaris product development and the person responsible for QA/RA are included in the project team. Guidance and advice will be provided continuously throughout the project period, where the hired expert provides both training and instructions to other project participants.