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)

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.

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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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About PRORA Regulatory Affairs Consulting

Regulatory Affairs / Quality / Labeling - Medical Device & Combination product CONSULTING.
Worldwide Registration, Technical File, Label&Leaflet Design, Regional Label Concept, Riskmanagement, Usability, Clinical Evaluation

PRORA Regulatory Affairs Consulting
Bundesstr. 25
HAMBURG,
20146

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