Compliance for software according to IEC 62304

Important results from the project

The project within Medtech4Health´s call for proposals strengthened Navari´s competence and working methods to develop a medical technology software in line with MDR and IEC 62304. Through workshop-based work with an external expert, a compliance strategy and V&V work plan were developed, central documentation was established and work on the necessary SOPs began. The results reduce regulatory risk and strengthen the conditions for upcoming clinical studies and commercialization.

Expected long term effects

The results achieved in the project will have clear long-term effects, including reduced regulatory risk and a shorter path to market as well as a more efficient development process. Navari´s team has also gained increased internal competence and organizational maturity, which strengthens decision-making and allows Navari to drive compliance work forward more independently. This in turn provides stronger credibility to external parties such as investors and authorities.

Approach and implementation

The project was implemented in three work packages through regular, workshop-based meetings on site at Navari with external experts and Navari´s development and QA/RA team. Activities related to: -Design of strategy for compliance according to IEC 62304 and associated work plan -Implementation of V&V and design of associated documentation in line with strategy and work plan designed in AP-1 -Design of necessary SOPs, identified in AP-1, for continued work towards a complete QMS