in accordance with DIN EN ISO 9001:2008 for the scopes: design, development, production and distribution of plastic components, particularly of cartridges, medical articles, laboratory products and building materials.
Quality Management System
for medical devices according to DIN EN ISO 13485:2003 + AC:2009
Requirements for regulatory purposes for the scopes development, production and distribution: Dialysis cartridges as well as accessories for in-Vitro-diagnostics (other IVDs from plastic) and plastic injection moulding articles for medical devices (non implants).
Full Quality Assurance System
for the design, manufacture and final inspection of the medical devices as specified in the enclosure within the scopes: dialysis cartridges, according to Dirctive 93/42/EEC, Annex II excluding (4).
