About Dr. Hatem Rabeh
Clinical Evaluation Expert for EU MDR 2017/745
Who I Am
I am Dr. Hatem Rabeh, a Medical Doctor with a Master’s degree in Biomedical Engineering and over 8 years of dedicated experience in clinical evaluation for medical devices under EU regulations.
I founded Clinical Evaluation Navigator to help MedTech manufacturers navigate the complex requirements of EU MDR 2017/745. My mission is simple: help you build clinical evidence that passes Notified Body review on the first submission.
My Background
Education
- Doctor of Medicine (MD)
- Master of Science in Biomedical Engineering (MSc)
Professional Experience
- 8+ years in clinical evaluation and regulatory affairs for medical devices
- Extensive experience with Notified Body submissions and CEAR reviews
- Worked across Class I, IIa, IIb, and III medical devices
- Deep expertise in EU MDR 2017/745, MEDDEV 2.7/1 Rev 4, and MDCG guidances
Core Competencies
- Clinical Evaluation Plans (CEP) and Reports (CER)
- State of the Art (SOTA) analysis and systematic literature reviews
- Post-Market Clinical Follow-up (PMCF) plans and reports
- Equivalence assessment under Article 61
- Benefit-risk determination and clinical data analysis
- Regulatory strategy for MDR compliance
What I Do
I provide end-to-end clinical evaluation consulting services for MedTech companies, from early-stage regulatory strategy through post-market clinical follow-up. My clients include startups seeking their first CE marking and established manufacturers transitioning from MDD to MDR.
Every document I produce is designed to withstand rigorous Notified Body scrutiny. I combine deep medical knowledge with hands-on regulatory experience to create clinical evaluations that are scientifically sound, regulatory compliant, and strategically aligned.
My Approach
- Evidence-based: Every claim is supported by clinical data, literature, or regulatory guidance
- Practical: I focus on actionable strategies that get your device to market
- Transparent: Clear communication, realistic timelines, no hidden complexity
- Up-to-date: I continuously track MDCG guidances, NB expectations, and regulatory trends
Connect with Me
I regularly share insights on clinical evaluation best practices, Notified Body expectations, and MDR compliance strategies.
- LinkedIn: linkedin.com/in/hatem-rabeh
- Newsletter: Clinical Evaluation Navigator on Substack
Ready to Work Together?
Book a free 30-minute consultation to discuss your clinical evaluation needs.
