The new european legislation requires new demands for industrials in order to set a rigorous and transparent legislative framework and to ensure a hign level of security and health protection.
In this context, our structure is composed of an entirely dedicated team consisting of qualified technicians and experienced project leaders who will accompagny you through out the execution and supervision of your evaluations in the reglulatory framework of CE and FDA requirements within our laboratories.
Besides the CE registration, our team is also at your service for FDA marking using a structure in New York composed of a CLIA laboratory, project leaders and technicians.
We perform all the testing required for technical file preparation of the product.
Expertise with CE IVD diective and FDA requirements and technical file specifications.