LICEMED


Set up and certification of a testing laboratory for medical devices ensuring the implementation of Europeean Directive 93/42/EEC transposed into national legislation: Proiect CEEX-MA-C2-2657

ROMANA

ENGLISH

METECUS Cluj

Summary

Project Set up and certification of a testing laboratory for medical devices ensuring the implementation of Europeean Directive 93/42/EEC transposed into national legislation aims at development of infrastructure for the evaluation and certification of conformity in Romania with the scope of attaining the competitivity and efectiveness level necessary for European Union integration of our country, the fundamental scope being the establishment of an Acreditated Testing Laboratory for the safety of electro-medical devices.

The Laboratory will permit access of the medical devices manufacturers and the other stakeholders (the public authorities for surveyance), to the performance-based services for evaluation and certification of CE conformity in the Transilvania region contributing in this way to the increasing of regional competitiveness.

An important component of this project is the laboratory endowment with the necessary equipment for testing and analyses and also the elaboration of the documentation necessary for the laboratory accreditation by RENAR.

Objectives

1. Asimilation and implementation of the testing, evaluation and implementation methods from the 93/42/EEC directive, for medical devices in conformity with the applicable EN60601 technical standards series.

2. founding and accreditation of the testing laboratory which offers conformity evaluation services for the potential clients.