Clinical Research

Clinical Research at TOBB KAMM

Scientific Excellence in Device Certification & Clinical Data Services
The Clinical Research Excellence Center (KAMM), established within TOBB University of Economics and Technology Medical Faculty Hospital, provides advanced clinical research services and comprehensive support for medical device companies throughout international certification processes. Our center serves both domestic and international manufacturers, offering tailored solutions to meet the requirements of FDA, the European Union Medical Device Regulation (MDR - 2017/745), and other regulatory authorities.

Our Core Services Include:

Clinical Research and Trial Management
Design and execution of high-reliability, ethically approved clinical trials; patient and data coordination; protocol development and reporting.
International Certification Support
Strategic consulting for:
FDA Clearance
CE Certification
MDR Compliance Documentation
Clinical Data Generation and Analysis
Collection, statistical evaluation, and transparent reporting of safety and efficacy data essential for device approval and market access.
Regulatory Consulting Services
In-depth support for:
Technical documentation preparation
Regulatory inspections and gap analysis
Market-entry strategies for Europe, the U.S., and global markets
Post-Market Surveillance & Clinical Follow-Up (PMS & PMCF)
Ongoing safety and performance monitoring after market entry, including:
Risk assessment
Clinical performance evaluation
Real-world data collection and analysis
Collaborative R&D Ecosystem
In partnership with our Faculty of Engineering and Technology Center, we accelerate device innovation through university-industry collaboration — from research and prototyping to validation and commercialization.
Education, Workshops & Knowledge Sharing
We offer specialized training programs, workshops, and webinars tailored to the evolving needs of medical technology professionals — enhancing clinical research competency across the sector.

From Research to Regulation — All in One Center

Our center provides an internationally compliant clinical research environment, built on transparency, scientific rigor, and regulatory precision. When required, we also collaborate with accredited laboratories and testing institutions to ensure the most reliable outcomes.Whether you're a start-up navigating regulatory pathways or an established manufacturer seeking robust clinical data, TOBB ETÜ Clinical Research Excellence Center is your trusted partner in delivering validated, high-impact medical technologies to global markets.

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