All medical devices meet the requirements set forth by Regulations 2017/745/EU and 2017/47/EU and the Medical Devices Directive Law 93/42/EEC.
Special attention to work sessions. At the beginning of every work session in the laboratory, the environment is sanitized with an Ozone Machine. Before beginning, the manufacturer sanitizes their hands and the tools that will be used, then puts on an overshirt or protective coverall, gloves, mask, and protective glasses.
When the products are complete, especially masks, they are checked to make sure they are properly sewn and finished. They are placed on a sterile cloth and sanitized again with ozone before being packaged and placed in the stocking area to be prepared for shipment.
In an area adjacent to the laboratory is the storage area for materials used in the construction of the devices and the packaging area for finished products, also carefully sanitized and protected from external agents.