From CE Marking to FDA registration,
we simplify complex international standards to unlock seamless market access for your products.
We are one stops solution for inspections, Trainings, CE marking , ISO certifications & testing of Electrical & electrometrical products; We provide customized solutions to help you achieve and effectively maintain regulatory and commercial success.
Read MoreFrom specialized CE Marking and ISO 13485 certification to rigorous medical software standardizations, we provide the authoritative regulatory guidance your business needs to unlock international markets confidently.
Navigating the complex landscape of international regulatory affairs, quality management, and compliance demands absolute precision. At KB International, we bridge the gap between complex global standards and your business goals, ensuring your products achieve market access efficiently and seamlessly.
“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.
“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.”
“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.”
