In Vitro Diagnostic Medical Device Services
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Manufactured by ORGENTEC Diagnostika GmbHbased in GERMANY
Our in vitro diagnostic medical devices (IVD) are CE marked. Our quality management system is certified according to ISO 13485 in the latest ...
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Manufactured by Visia Lab Srlbased in ITALY
constant growth over the years thanks to the development of proprietary technologies and a constant commitment to research and development of innovative, disruptive in-vitro diagnostic medical devices. All phases of the design and production process are carried out at the San Giovanni Valdarno production ...
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by STEMartbased in USA
CE marking is the manufacturer's declaration that their product complies technically and administratively with the essential regulatory requirements of Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC, Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and In Vitro ...
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Manufactured by in.vent Diagnostica GmbHbased in GERMANY
ICS is the newest expansion of our service portfolio. We have harnessed our 20 years of expertise in diagnostic studies to conceive a new level of IVD-services: A complete all-round package covering every step of diagnostic assay validation, including all performance studies, study protocols, and ...
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based in GREECE
CE Marking is the symbol as shown on the top of this page. The letters 'CE' are the abbreviation of the French phrase 'Conformité Européene' which literally means 'European Conformity'. The term initially used was 'EC Mark' and it was officially replaced by 'CE Marking' in the Directive 93/68/EEC in 1993. 'CE Marking' is now used in all EU official ...
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by Metecon GmbHbased in GERMANY
An audit is the most effective method to establish certainty that you as the manufacturer or distributor of medical devices are in the position to meet all requirements. Metecon offers comprehensive support in this regard with a wealth of experience and know-how. Take a moment to get an overview of our services. And if you see any need, we ...
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