Quality

Medcare, which produces by prioritizing quality, has created its quality management system according to the ISO 13485 standard. Products and quality system have been certified by Notified bodies according to the 93/42/EEC directive and the 2016/425 PPE regulation, and by Certification bodies according to ISO 13485 and EN 13795-1 standards.
Medcare has also received FDA 510(k) clearance for its AAMI Level 4 Surgical gowns.

Medcare Underpad and Adult diapers-pants have an EAC Certificate approved by Russia and Eurasian Customs Union.
Process and final quality control of Medcare products is carried out according to the sampling method in the ISO 2859-1 standard, and if nonconformities are detected, all nonconformities are reported to the Quality Department and recorded, and improvements are planned.

Packaging devices, EO sterilization devices and all other equipments used in the production area and affecting products are validated according to the approved methods at a certain period.