A New Level of Regulatory Affairs Medical Devices Consulting
A cost-effective alternative to the classic RA and QM consulting. The new approach relies on combining on site consultation together with the ®PRORA-DaaS service remote support. (DaaS: Department as a service)
Germany, December 14, 2015 (Newswire.com) - This company offers a cost-effective alternative to the classic RA and QM consulting. The new approach relies on combining on site consultation together with the ®PRORA-DaaS service remote support. (DaaS: Department as a service) After a short free sign up process customers have direct access to a high level of expertise. The client area provides direct access to projects and inquiries. Combining remote and on site support assures a smooth run of projects. This method brings cost and time saving through fixed prices/quotations and also helps to avoid bottlenecks within the overloaded departments.
New topics such as MDR (Medical Device Regulation) and UDI (Unique Device Identification) will challenge the departments in future.
Important bullet points:
– Free sign up / Client Center
– Quick project start
– Fixed prices (dependent on the project)
– Project scope: one task -> long term
Company expertise:
– Regulatory Affairs
– MDR
– Quality Management
– Label&Leaflet Management
– Artwork Design
– UDI
– Risk Management
– Usability
– Clinical Evaluation
– Translation
– Technical File
– Registration
Markets:
– World wide
For the sake of completeness:
Argentina, Australia, Brazil, Canada, China, Colombia, Costa Rica, Egypt, Europe, Hong Kong, India, Israel, Japan, Malaysia, Mexico, New Zealand, Peru, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United States
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Tags: consulting, labeling, MDR, medical devices, quality management, registration, Risk management, technical file, UDI
