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 ↓
Video Introduction

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

      • Professional compliance guidance

        Guide you (including on-site) to complete the system specification of certification project requirements

      • Professional technical report

        Write the technical review report to meet the requirements of the audit agency

      • Follow up and grow together

        To establish long-term and stable strategic partnership with you, and continue to escort you

    • Consulting team
      • Guidance
      • Professional report
      • Welcome to join

    Teams of Osman™

    Our branches are around the world, together to provide you with the best quality certification consulting services

    Get started ->
    The audit opinion of NB came out!
    Good! I'll answer them ASAP~
    • Simple pricing!

      • [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

      Start for free ->

      No credit card needed.

    • U.S FDA related

      Low from


      Annual payment according to the FDA

      EU CE related

      Low from


      One time payment, no fees for up to 5 years

    More compliance certification consulting services

    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 ->

    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.