About Dr. Hatem Rabeh
Clinical Evaluation Consultant | 60+ CERs | Notified Body Collaboration | EU MDR Expert
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 across Europe 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.
What sets me apart is my dual perspective. I have both prepared clinical evaluation documents for manufacturers and reviewed them from the Notified Body side. With more than 60 Clinical Evaluation Reports delivered across Class I, IIa, IIb, and III medical devices, I know exactly what reviewers look for and where most submissions fall short.
My Background
Education
- Doctor of Medicine (MD)
- Master of Science in Biomedical Engineering (MSc)
Professional Experience
- 60+ Clinical Evaluation Reports written and reviewed across Class I, IIa, IIb, and III medical devices
- Dual perspective: prepared CERs for manufacturers and reviewed clinical evaluations from the Notified Body side
- Direct collaboration with EU Notified Bodies, including co-hosting webinars
- 8+ years in clinical evaluation and regulatory affairs for 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
Speaking & Events
I regularly share my expertise at international MedTech conferences and educational events:
- CSMD-Horizon Congress — Invited speaker on clinical evaluation topics. View speaker profile
- European Medical Writers Association (EMWA) — Speaker on clinical evaluation under MDR and IVDR, practical updates and implementation strategies for medical writers. View event
- SOTA Webinar with Notified Body Szutest (NB 2975) — Co-hosted webinar on State of the Art analysis under EU MDR. Watch recording
- AI & SaMD Webinar — CE marking for AI-based Software as a Medical Device under MDR and AI Act. Watch recording
What I Do
I provide end-to-end clinical evaluation consulting services for MedTech companies across the European Union, 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 and a reviewer’s perspective 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
- Reviewer-informed: My Notified Body experience means I anticipate reviewer questions before they arise
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.
