The audit was carried out by the independent assessment body BSI Group and confirms Lumito’s clear focus on quality, safety, and regulatory compliance. The Company was certified according to ISO 13485:2016 in 2022 and has since undergone annual audits to ensure that the quality management system continuously meets the requirements of the standard.

”The certification is an important part of ensuring high quality in our work processes and demonstrates that our systematic quality efforts function in practice. It confirms our commitment to quality and safety at every stage”, says Sanna Wallenborg, CEO of Lumito.

ISO 13485:2016 is an international standard that defines the requirements for quality management systems (QMS) for manufacturers of medical and diagnostic devices. The certification supports the Company by establishing documented and controlled processes for quality, risk management, and regulatory compliance. This is an important foundation for future work to bring a medical device intended for diagnostic use to the market.