Sentinel CH SpA  is an Italian company founded in 1983.
For over twenty years Sentinel has been committed to the development of innovative IVD devices in the bid to make clinical diagnosis ever more reliable.
In 2006 Sentinel moved to new high-tech premises covering a total area of about 10.000m².
The company is ISO 9001:2000, ISO 13485:2003 and ISO 13485:2003 CMDCAS certified.
Sentinel is compliant with the European Directives (98/79/CE), 21C CFR 820 "Code of Federal Regulations" FDA (U.A. Food and Drug Administration), SOE-98-282 (Canadian Medical Devices Regulations) as well as with directives of other countries, including Canada (CMDCAS). The facility, equipments and Quality System are regularly audited by Certification Body, Registrar Body and by customers and inspected by the National Competent Authority and FDA.
Sentinel's commitment to comply with IVD regulations has facilitated and supported successful partnerships in the industry as well as the distribution of Sentinel's products in over 70 countries worldwide.
Sentinel has an active presence at the major international congresses, presenting posters written by its specialised scientists. Sentinel is an active partner of IRMM projects for the release of new References Preparations for proteins.
The Technical and Manufacturing departments count for 70% of the company.
More than 100 different assays, under our own brand and also as customized kits, are manufactured in contamination-free clean rooms (ISO 8 and ISO 7 qualified).
The company's main areas of activity are:

The new Molecular Biology department initiated in 2008 has its own Production clean rooms (ISO 7) as well as R&D laboratory.
Sentinel Diagnostics: "Watching over Life"

Roberto Boggio, PhD
Research & Development Manager
Via Robert Koch, 2
20152 Milano
Italy
Tel.: +39 02 3455141
Fax: +39 02 34551464
Website: https://www.sentineldiagnostics.com/