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.com
Outlook
Mobile Friendly
Nginx
Google Tag Manager
Shutterstock
WordPress.org
YouTube
Remote
Keywords
in vitro diagnostic
medical device
regulatory consulting
quality management consulting
medical writing service
performance evaluation report
clinical evaluation report
ivdr
mdr
qms
clinical study services
clinical investigation
clinical performance study
qms services
risk management services
technical documentation
medical equipment manufacturing
ai and software services
eu mdr and ivdr
notified body support
qms iso13485
post-market surveillance
medical devices
post-market surveillance reports
consulting
research and development in the physical
engineering
and life sciences
ivdr literature search
iso standards
Company Information
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Employees 7
Location
Jahnplatz, Graefelfing, Bayern, Germany, 82166
