Global market compliance certification consulting services for medical devices
Product categorization, testing and certification program planning; quality system certification counseling; regulatory training
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Major consulting services
We're good at the following certifications
U.S FDA registration
All medical devices, foods, cosmetics, and laser radiation products intended to be legally marketed in the United States must be registered with the FDA
FDA 510K clearance
Non-exempt medical devices must pass the certification items. Covers a small number of Class I, most class II and very few Class III products
FDA U.S Agent
FDA rules: all non-AMERICAN enterprises selling medical devices in the United States must appoint an agent in the United States
EU CE marking
It is mainly MDR certification for general medical devices and IDVR certification for in vitro diagnostic medical devices
ISO 13485 Certification
The quality system certification must be completed before medical devices pass CE certification
EU Authorized Representative
The EU Commission requires that all foreign companies selling products to EU must have an authorised representative inside EU
Features of Osman™
In addition to providing you with professional compliance guidance, our professional technical reports are more easily recognized by audit agencies. Can save a lot of time and cost for your product testing certification
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Professional compliance guidance
Guide you (including on-site) to complete the system specification of certification project requirements
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Professional technical report
Write the technical review report to meet the requirements of the audit agency
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Follow up and grow together
To establish long-term and stable strategic partnership with you, and continue to escort you
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Teams of Osman™
Our branches are around the world, together to provide you with the best quality certification consulting services
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The audit opinion of NB came out!
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More compliance certification consulting services
Our goal is to help you to pass all the compliance procedures before the product goes on sale
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[CHINA] NMPA related
Registration / certification, licenses of medical devices (including imported)
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[AUSTRALIA] TGA related
Certification must be done for medical devices and food products in Australia
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[CANADA] HC related
Certification must be done for medical devices and food products in Canada
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[UK] UKCA / MHRA related
UKCA marking and MHRA registration for medicial devices
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[BRAZAL] ANVISA related
Certification must be done for medical devices and food products in Brazil
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JP/KR/RU/IDN etc.
Certification must be done in Japan, Korea, Russia and Indonesia etc.
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MDSAP
One single audit for coving of the United States, Canada, Japan, Brazil and Australia
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More System Certificaition
ISO 9001/15378/22716/14001/45001 / FDA QSR 820
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FSC Certification
Including Forest Management(FM) and Chain of Custody(COC)
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Don’t wait and start now!
Business opportunities wait for no one, and many times the market winner is just one step ahead of others. It can help your products pass the compliance audit as soon as possible if you entrust Osman as your certification consulting service provider.
