Certificates of Quality
Certificates of Quality
The company meets the requirements of the
management quality system according to the standard for medical
device EN ISO 13485 and also conforms to the quality system for
final products testing, etc. according to Directive 93/42/EEC for
medical devices (appendix II, paragraph 3). This confirmation of
the high quality of products is also an inevitable step in gaining
a market share in EU countries and increasing the company's
prestige.
SpofaDental a.s. obtained its ISO certificate and CE
certificate from renowned German auditor company TŰV NORD. This
certificate acknowledges the implementation and use of a system
that guaranties quality in conformity with European Standard ISO
9001 in the field of development, production and distribution of
filling materials, resins, impression materials and acrylic
teeth.
The company meets the requirements of the management
quality system according to the standard for medical device EN ISO
13485 and also conforms to the quality system for the development,
production, inspection and sale of products, etc. according to
Directive 93/42/EEC for medical devices (appendix II, paragraph 3).
This confirmation of the high quality of products is also an
inevitable step in gaining a market share in EU countries and
increasing the company's prestige.