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.

Relevant national and international guidelines and legislation are converted into standard operating procedures or directives and are regularly audited. As a result our quality management systems comply, among others, with EN ISO 9001 and EN ISO 13485 as well as the FDA Quality System Regulation and the Canadian Medical Device Regulations.