Regulatory affairs support for breakthrough NPI in imaging technology

Project status
Project start date
Not specified
Project posted
18 Jul 2016 16:51
Project duration (approx.)
360.0 Days
Budget (approx.)
€480 / day
Industry
Medical Devices / Technology
Area of expertise
Product Development , Legal / Compliance
Consultant location
On-site
Location
Netherlands
Languages
English (Essential)

Objectives and Key Deliverables

We are planning NPI for a novel breakthrough first of a kind product in imaging technology and would benefit from Regulatory Affairs experience in the (invasive) medical devices area to support the project through its' initial registration in US and EU.

Regulatory file for FDA submission in US
Technical file ready for NB assessment in EU

Ample experience in registration of highly complex systems; experience in registration of sterile disposables

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