About
Requalite provides Regulatory, quality, and Clinical Study services for in vitro diagnostic and medical device compliance in EU. Requalite is located at the heart of Europe, in Munich-Germany. We provide full CRO services for clinical studies as per IVDR/MDR. In addition, we provide Technical and medical writing services to manufacturers of Medical Device and In vitro Diagnostic devices to obtain CE-marking as per EU regulations of MDR (2017/745) and IVDR (2017/746) for entering European market.
Technologies
Wordpress.comOutlookMobile FriendlyNginxGoogle Tag ManagerShutterstockWordPress.orgYouTubeRemote
Keywords
in vitro diagnosticmedical deviceregulatory consultingquality management consultingmedical writing serviceperformance evaluation reportclinical evaluation reportivdrmdrqmsclinical study servicesclinical investigationclinical performance studyqms servicesrisk management servicestechnical documentationmedical equipment manufacturingai and software serviceseu mdr and ivdrnotified body supportqms iso13485post-market surveillancemedical devicespost-market surveillance reportsconsultingresearch and development in the physicalengineeringand life sciencesivdr literature searchiso standards
Company Information
- Employees7
Location
Jahnplatz, Graefelfing, Bayern, Germany, 82166
