The project will run from May to December 2026 and is intended to strengthen the Company’s regulatory competence, with a particular focus on quality management systems during the commercialisation phase. The initiative includes identifying and clarifying regulatory requirements, processes and areas of responsibility, as well as further developing operational procedures tailored to commercial sales to industrial customers, research organisations and pharmaceutical companies.

The project will also include an assessment of relevant quality standards and frameworks, including ISO 13485, ISO 9001 and GLP frameworks, as part of the Company’s regulatory strategy and continued development. The goal is to ensure a quality management system that is aligned with both regulatory requirements and customer expectations, while supporting the Company’s long-term strategic direction, including future steps towards IVDR compliance.

The project will support a more scalable and efficient way of working, with greater internal alignment around quality, responsibilities and customer offering, while reducing the risk of future regulatory obstacles and unnecessary administrative burden.

“We are delighted to have been awarded this funding from Vinnova and Medtech4Health. It strengthens our ability to develop both our organisation and quality management systems in line with our commercialisation efforts, with the aim of establishing a fit-for-purpose and efficient quality system that supports both our current needs and the next stage of our development,” says Sanna Wallenborg, CEO of Lumito.