KB INTERNATIONAL

KB International is your regulatory compliance partner for Medical Device

WHO WE ARE

WHO WE ARE

 

We are a leading Total Quality Assurance provider specializing in the field of medical devices industry worldwide. We are one stop solution for inspections, trainings, CE marking, ISO certifications & testing of electrical & electromedical products. We provide customized solutions to help you achieve and effectively maintain your regulatory and commercial success.

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ONE STOP SOLUTION

  • Testing and certification for faster regulatory approval
  • Total Quality Assurance across your supply chain
  • Rapid & efficient entry to virtually any market in the world
  • Innovative leadership in meeting social accountability standards
  • Name and fame as a trusted and assured brand in the market
  • Increased Product demand and overall profit.

Clients' Reviews

“KB International performed a facility GMP audit at our unit in Hungray, and we were very pleased with the report provided. It was comprehensive, practical and clearly indicative of what was actually missing and what an FDA inspector would look for in 21 CFR 820. We are appreciative of the level of service we received at very reasonable rates.”
Adam Sendler
Designer
“I’m really pleased with the service and support I received from KB International. The team has clearly identified the device classification and made the necessary modification in the naming as per FDA Product Code. They helped us to complete the registeration and listing with USFDA within 14 working days.”
Mila Kunis
Manager
“I’ve worked with KB Intl, Hungray for the technical file preparation of our medical device with an ancillary drug. The team involved was technically sound, friendly & cooperative. The team used a cloud-based software, so that all developments were timely discussed and corrected. This helped us to close the project before schedule.
Mike Sendler
Support