For many decades b2bio's industry partners have been developing and manufacturing instruments for many leading IVD-, Medtech-, and Life Sciences companies.
Since then more than 300 development programs have been completed, and millions of instruments have been manufactured and delivered to laboratories worldwide.
How about outsourcing your next instrument project to us, too?
Get us on board and we will drive your project according to your product road map, and in line with the requirements of DIN EN ISO 13485 and 14001, as well as FDA 21 CFR Part 820 for Class I through Class III Medical Devices.
Over and above the development of your instruments, necessary documentation will also be prepared to get your product approved with local regulatory bodies, such as the FDA.
Core competencies include Molecular Diagnostics, Clinical Chemistry, Immunodiagnostics, Coagulation, and Microbiology
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In addition to the series production of your instruments we also take care of all facets of product life cycle management, incl. spare-part and obsolesence management, after sales services, product support and improvements, as well as product portfolio development.
+49 861 2097162
a.wehren@b2bio.de
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