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In 1998, Chemichl AG introduced a Quality Assurance System
and is certified according to the most up to date standard in the field
“development, production and distribution of dental ceramics and
accessories” in accordance with the
ISO Standards 9001:2000 (Quality Management Systems) and ISO 13485:2003 (Quality Management Systems for Medical Products). For the sales in Europe, the EC-Guideline-Certificate with the Certification according to the medical products Guideline 93/42/EEC, Appendix II is decisive. The dental ceramic materials are classified as class IIa products, except for the dental accessories and supporting materials. In the growing competition, certifications often turn out to be purchase decisive factors for quality and security.
These medical products are "semi-fabricates",
which are then processed by trained dental technicians to produce dental
restorations, to be finally inserted by the trained dentist into the
patient’s mouth.
We are pleased to have found in our Notified Body "DEKRA-ITS" an experienced and accepted partner, with whom our quality becomes visible. |