The regulated platform behind health technology.
KeborMed builds and runs Kubyk, a platform in production since January 2020.
Medical devices · Digital health · Digital pharma · AI SaMD
- Drive DeVilbiss Healthcare
- Veranex
- Diality
- University Hospitals
- Unephra
- AutonomUS Medical Technologies
- BrightUro
- Nova
- Octo
What we do
We build and run regulated infrastructure for health technology.
Health technology companies put their products on infrastructure KeborMed builds and runs, so their teams can spend their time on the product.
- In production
- 2020
- First customer live, January 2020.
- On the platform
- Tens of thousands
- Devices and patients since 2020.
- FDA Master File
- Active
- Referenced in multiple cleared 510(k) devices.
Quality and trust
Certified, and on record.
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
ISO 13485
- Issuer
- NQA
- Number
- 22124
- Status
- Recertified 2026, valid through 2029
Information security
ISO 27001
- Issuer
- NQA
- Number
- 23339
- Status
- Valid through 2027
FDA
Master File
- Covers
- The platform core, on average 80% of any solution's code base
- Status
- Active, and referenced in multiple cleared 510(k) devices
- Updates
- Continuous security, performance and feature updates, all at KeborMed's cost
Documents you can request.
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
The team behind KeborMed.
Radu Iancu, MD, PhD
Founder and Chief Executive Officer
A cardiologist and computer programmer, Radu has spent his career bridging medicine and technology.
Nikolaos Fikas
Chief Security Officer
Niko leads the security and integrity of KeborMed's systems, with extensive experience in regulated healthcare.
Mugur Vasile
Solution Architect
Mugur works across back-end and mobile, and is behind many of the platform's most inventive solutions.
Ciprian Iuga
Solution Architect
Cip brings deep front-end and programming experience, and is the engineer the team learns from most.
Igor Corna
VP of Operations
A software engineer turned technical project manager, Igor sets high standards for the team and for himself.
Ana-Maria Piso-Grigore, PhD
R&D Lead
An astrophysicist educated at MIT and Harvard, Ana leads research and development, including machine learning.
Talk to us
Talk to KeborMed.
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