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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

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

Date founded

2012

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