Products and related services of consistent quality

To support our mission and vision, CleanNA produces reagents and kits of consistent quality. The customers we aim to serve are in the top segment of the life science market, scientific researchers as well as diagnostic laboratories. They work with validated procedures, and therefore require kits and reagents that meet their quality standards, with proven batch to batch consistency. The management team sees the requirements of EN ISO 13485:2016 as a means to structure the company processes, thereby supporting the mission and vision of the company.

Our customers in diagnostic laboratories need products with the CE mark in order to meet legal EU requirements. Therefore CleanNA will gradually launch CE marked reagent kits into the market, and setup the processes to meet the requirements of the IVDR.

All members of the CleanNA staff actively contribute to the QMS either by participating in work groups, writing and reviewing standard operating procedures and work instructions, or by performing validation procedures. We believe this leads to a thorough understanding of the quality concept throughout our organization and a risk based continuous improvement of our processes. EN ISO 13485:2016 requirements will provide the framework to monitor and review if we meet our quality objectives, and improve our performance accordingly.