TESTS AND ANALYSES - THEMES

How can CENIC laboratory help?
CENIC laboratory performs marking tests for CE, FDA and other regulating agencies, conforming to international quality standards and certified to ISO IEC 17025 by INMETRO’s CGCRE, signatory member of ILAC. Bilingual reports in Portuguese/English obviate the cost of a sworn translation.

CE Marking
For commercialization of medical devices within the European Communion manufacturers are required to have a CE marking certification.
Directive 93/42/CEE defines the requisites for obtaining the certification , including test requisites.

Class III, IIb and IIa devices have test requisites such as: 
• Documents of tests realized before, during and after manufacture (annex II and V – item 3.2);
• Tests to check if the pertinent standards were effectively applied (annex III – item 4.3);
• Adequate tests proving product compliance with the directive’s requisites (Annex IV – item 4);
• Tests to be carried out after manufacture (Annex VI – item 3.2).

FDA
For commercialization of healthcare products in the United States the manufacturers must register their product with FDA-Food and Drug Administration. To this effect the manufacturer must submit to FDA a premarket notification – also called PMN or 510(k).
Under 510(k) the manufacturer submits a study of the product  to be registered, as compared to one or several similar products which are already being legally commercialized on the American market.
Contact CENIC laboratory for performing comparisons of your product with the market product. We carry out tests in accordance with your special and strategic necessity.