Global market compliance certification consulting services for medical devices
Product categorization, testing and certification program planning; quality system certification counseling; regulatory training
Start now -> Explore features ↓Product categorization, testing and certification program planning; quality system certification counseling; regulatory training
Start now -> Explore features ↓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
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
Guide you (including on-site) to complete the system specification of certification project requirements
Write the technical review report to meet the requirements of the audit agency
To establish long-term and stable strategic partnership with you, and continue to escort you
Our branches are around the world, together to provide you with the best quality certification consulting services
Get started ->[Not cheating] adopt long-term win-win pricing strategy, reasonable price
[Low threshold] New customers experience our quality services at a lower cost
[Care about] Regular customers continue to get long-term cooperation discounts and priority
[Together grow] Channels and peers can treat each other with courtesy and seek common development
The price is transparent and worry-free. All sales adopt uniform quotation
Reasonable fees are charged according to the progress of the project and refunded according to the final result
No credit card needed.
Our goal is to help you to pass all the compliance procedures before the product goes on sale
[CHINA] NMPA related
Registration / certification, licenses of medical devices (including imported)
[AUSTRALIA] TGA related
Certification must be done for medical devices and food products in Australia
[CANADA] HC related
Certification must be done for medical devices and food products in Canada
[UK] UKCA / MHRA related
UKCA marking and MHRA registration for medicial devices
[BRAZAL] ANVISA related
Certification must be done for medical devices and food products in Brazil
JP/KR/RU/IDN etc.
Certification must be done in Japan, Korea, Russia and Indonesia etc.
MDSAP
One single audit for coving of the United States, Canada, Japan, Brazil and Australia
More System Certificaition
ISO 9001/15378/22716/14001/45001 / FDA QSR 820
FSC Certification
Including Forest Management(FM) and Chain of Custody(COC)
Don’t want to miss the solution?
Get started ->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.
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