novineon CRO GmbH

medical devices

About

novineon CRO GmbH is a consulting and research company in the field of health care technology. As a professional service provider, we support international manufacturers of medical devices and in-vitro diagnostics. In close relationship with our clients, we actively manage all aspects of preclinical and clinical research, clinical evaluation, PMS (post-market surveillance) and PMCF (post-market clinical follow-up) strategies as well as performance evaluation. Furthermore, we offer regulatory services in conformity assessment procedures, also in non-European markets. We collaborate with clinical experts and recognized specialists in their respective fields for clinical evaluation and special medical and regulatory issues. novineon CRO GmbH is certified according to ISO 9001:2015 for pre-clinical and clinical contract research in the field of medical technologies and are regularly audited by DEKRA Certification GmbH.

Technologies

Outlook Microsoft Office 365 Mobile Friendly Apache

Keywords

clinical evaluation clinical studies sscp biological evaluation fda submission postmarket surveillance pmcf performance evaluation user experience klinische studien klinische forschung monitoring-plan literaturauswertung pms-pläne pharmaceutical & medicine manufacturing data management pharmaceuticals medical research & development projektmanagement in-vitro-diagnostika regulatorische beratung datenmanagement risikoanalyse klinische datenanalyse biostatistik klinische studien für medizinprodukte regulatory compliance leistungsbewertung zulassungsstrategie design-verifizierung

Location

Friedrich-Miescher-Strasse, Tuebingen, Baden-Wuerttemberg, Germany, 72076

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