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Processes in place for ISO 13485 qualification

Confirmation from an independent auditing company now shows that Lumito has the processes in place to qualify for ISO 13485. The first step has been passed and the next step in the process is for the company to demonstrate that the processes are being followed in practice. The processes reflect that the company is well prepared for the requirements of the IVDR Regulation.

- This was the first time that we were audited by an independent auditing company, a so-called notified body. I am both proud and pleased with the good work of our employees, which has meant that we are ready for step two in the company's journey towards ISO 13485 certification," says Mattias Lundin, Lumito's CEO.

 

For further information, please contact

Mattias Lundin, CEO of Lumito, e-mail: ml@lumito.se.


Lumito specializes in imaging technology within medical research and development. The technology is based on so called UCNP:s (Up Converting Nano Particles) and is aiming to increase image quality in biomedical applications.  Lumito´s IPR covers high-quality imaging of tissue, for instance in tumours, with UCNP:s as markers. The technology has several possible application areas, but Lumito has initially decided to focus on digital pathology. www.lumito.com

Lumito's share is traded under the ticker LUMITO on the Nordic Growth Market, NGM SME, where the Company's mentor is G&W Fondkommission, telephone: +468-503 000 50.



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