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Operon Strategist | Medical Device Consultancy, 510 k Consultancy, Turnkey Project Consultant

29 employees

A medical device regulatory consultancy. Regulatory assitance to various manufacturers of medical devices and primary packaging material.

Basic info

Industry

business consulting and services

Sectors

ISO 15378 Consultant
Design and Development of Medical Devices
US FDA 510 k Clearance
Medical Device Turnkey Project Consultant
Plant layout design consultant
clean room design consultant
ANVISA Registration
Combination Device Manufacturing
primary packaging project consultant
US FDA 21 CFR Part 211
CDSCO Import License
Consulting
US FDA 21 CFR Part 210
CE Mark Consultant
ISO 13485 Consultant
TGA Registration
US FDA Registration
FDA Consultant
US FDA Consultant
FDA 510(k)

Date founded

2012

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