Certified Operation

Instrumentarium Dental operates according to the following international standards and directives:

DIRECTIVE 93/42/EEC

(Medical Devices Directive)

ISO 13485:2003

 

ISO 9001:2008

 

ISO 14001:2004

Environmental Management System Certification

 

The Quality Management System complies with US law 21 CFR part 820 (Quality System Regulation)

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