KeborMed builds and runs Kubyk, a platform in production since January 2020.
Medical devices · Digital health · Digital pharma · AI SaMD
What we do
Health technology companies put their products on infrastructure KeborMed builds and runs, so their teams can spend their time on the product.
Quality and trust
KeborMed's quality management system is ISO 13485 certified, and its information security management system is ISO 27001 certified. Each certificate states its scope.
Quality management system
Information security
FDA
When an auditor, a hospital's security team or a grant reviewer asks how your product is built and run, KeborMed answers with you. We provide our ISO 13485 and ISO 27001 certificates, our quality policy, a security summary and a standard security questionnaire response, and we back your grant applications, security reviews, supplier assessments and audits with the documentation each one calls for.
KeborMed also takes the position of a critical supplier in your quality management system. Under a Quality Agreement, we maintain the QMS for the platform your product runs on, so your team can rely on ours instead of building and maintaining that part itself. And we go beyond the documents: we train your development, quality and regulatory teams on the platform itself, so your engineers build on it with confidence and your quality and regulatory staff can account for it in any audit or submission.
Team
Founder and Chief Executive Officer
A cardiologist and computer programmer, Radu has spent his career bridging medicine and technology.
Chief Security Officer
Niko leads the security and integrity of KeborMed's systems, with extensive experience in regulated healthcare.
Solution Architect
Mugur works across back-end and mobile, and is behind many of the platform's most inventive solutions.
Solution Architect
Cip brings deep front-end and programming experience, and is the engineer the team learns from most.
VP of Operations
A software engineer turned technical project manager, Igor sets high standards for the team and for himself.
R&D Lead
An astrophysicist educated at MIT and Harvard, Ana leads research and development, including machine learning.
Partners
KeborMed works with partners across software development, cybersecurity and clinical research, and the network keeps growing. A few of them are below; tell us about your project and we will introduce the partner who fits it.
Software development firms certified by KeborMed to design, build and integrate products on Kubyk, with KeborMed behind the platform they build on.
Cluj-Napoca, Romania · founded 1998
The largest technology company listed on the Bucharest Stock Exchange, with more than 1,200 engineers. Its Berg Software unit in Timișoara, experienced in biomedical and medical device software, has been an official implementation partner for KeborMed's platform since 2024.
Specialist firms that test and secure the medical devices and products built on Kubyk, for premarket submissions and postmarket surveillance.
Medical device cybersecurity
Exploitability management for medical devices: AI-driven penetration testing, FDA vulnerability verification, a living SBOM with VEX, and incident response, built for FDA §524B and EU MDR requirements. KeborMed and Elton Cyber have worked together on multiple FDA 510(k)-cleared devices.
Health systems and academic medical centers that work with us on clinical research and the evidence behind connected care.
Cleveland, Ohio
The academic health system of Northeast Ohio, home of UH Cleveland Medical Center and affiliated with Case Western Reserve University School of Medicine. University Hospitals and KeborMed are partners on an NIH R01 diabetes research grant.
Talk to us
Partners, investors, press, and quality or regulatory questions. A person at KeborMed reads every message and replies by email.
Building a connected medical product? The platform has its own contact.See the platform