Certificates

Quality Management System

for medical devices according to EN ISO 13485:2012 and EN ISO 13485:2012/AC:2012

Scope: Design and development, manufacture and distribution of dialysis cartridges as well as accessories for In-vitro Diagnostics (other IVD from plastic) and plastic injection moulding articles for medical devices (non implants).

Management System Certificate

In accordance with ISO 50001:2011, this certificate is valid for design, development, production and distribution of plastic components, particularly of cartridges, medical articles, laboratory products and building materials.

Quality Management System

In accordance with ISO 9001:2015 for the scopes: design, development, production and distribution of plastic components, particularly of cartridges, medical articles, laboratory products and building materials.

Declaration of Compliance

Suitability of materials used according to the current valid regulation (EC) No. 1907/2006 (REACH)

Déclaration de conformité

Aptitude des matériels utilisés conforme au règlement actuel CE no. 1907/2006 (REACH)