The ISO 13485-2017 standard regulates the mandatory stages of control and documentation that a medical device must go through during the manufacturing process, provides transparency of the origin of components and the quality of manufacturing, assembly, testing of products.
Now "Trobio" in its own production manufactures a compact portable thermocycler "BioExpert" (RU No. RZN 2021/13188 dated January 15, 2021), and plans to expand the line of analytical medical and research equipment.