Products

Certificates

We are committed to producing products complying with all regulatory requirements in terms of safety, efficacy, and reliability, thereby guaranteeing customer satisfaction.

We only employ methods, procedures, and resources commensurate with state of the art in both science and technology. All phases of development, manufacturing, quality control, and distribution are closely monitored and documented. For all processes standard operating procedures are available.

Our quality management system follows relevant national and international guidelines and legislations and is in compliance with IVDD 98/79/EG, EN ISO 13485:2016, FDA Regulations, and the Medical Device Single Audit Program.