Our Company Quality System complies with the European Standard ISO 13485:2012 which specifies the guidelines for application of the ISO 9001
standards in R&D, design, manufacturing, installation, and service
of medical devices.
All our products are CE certifiied according to the MDD 93/42/ECC and its revised version and a part of them according to the FDA Quality Systems Regulation 21 CFR.820.
We always control the bioburden contamination level of products that need to be sterilized, and to guarantee the maintainance of a minimum level of contamination some critical steps of the manufacturing process are made in a Clean Room (ISO 8).