Quality System

A strict Quality Assurance System warrants the design, production, quality control and distribution of products which complies with defined specifications and regulatory requirements.

Mascia Brunelli / Biolife Italiana are certified for such activities by MDC, Medical Device Certification GmbH, Stuttgart, Germany for In Vitro Diagnostic Devices pursuant to EN ISO 9001:2000, ISO 13485.

IVD products are manufactured and distributed in compliance with European Directive 98/79/CE.

Quality Policy