Cerba Xpert combines a unique expertise from routine clinical biology to esoteric testing, access to an unsurpassed variety of specimen, in depth knowledge of local and international regulation.
We carry out benefits enabling the technical file creation prior to the registration in accordance with the intructions of the notified organizations.
Samples, studies and ICF under GDPR regulations.
- Barcode-based tracebility system and use.
- Transport of samples compliant with IATA standards.
- Flexibility to specific or unusual orders.
- Reactivity and adaptability to changes in experimental designs.
- Accurate information about actual and forecasted stocks.
- Dedicated technical contact.
The new european legislation requires new demands for industrials in order to set a rigorous and transparent legislative framework and to ensure a high level of security and health protection.
All our laboratories are ISO 9001 certified.
All our laboratories are ISO 15189 certified.
In this context, our structure is composed of an entirely dedicated team consisting of qualified technicians and experienced project leaders who will accompany you throughout the execution and supervision of your evaluations in the reglulatory framework of CE marking within our laboratories.
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 clearance process 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, qualified project leaders and technicians.