Why Choose CER Navigator
Clinical Evaluation Navigator
Get Reliable Clinical Expertise for Swift and Successful CE Approval of Your Medical Device
Invest your time and efforts in running your business. Leave the clinical documentation (CEP, CER, PMCF, CIP, and IB) to me.
- Trusted
- Experienced
- Professional
THIS IS
Who I Am and What Drives My Mission
Hatem RABAH, MD, MSc Medical Engineering
I’m Dr. Hatem Rabeh, the heart of Clinical Evaluation Navigator. As a medical doctor, medical engineer, and clinical data scientist, I bring a unique mix of expertise to the table. I understand how challenging it can be to get CE approval for your medical device. That’s where I come in – to simplify and speed up this process for you.
Over my career, I’ve developed and tested a method that makes the clinical evaluation process quicker and more straightforward. This means you can get your device approved without the usual stress and delay. My goal is to guide you smoothly through the CE requirements, ensuring your medical device not only meets but excels in the market.
With my comprehensive background and proven approach, I’m committed to guiding you every step of the way. Together, we can turn the dream of launching your medical device into a reality, with less stress and more confidence in achieving fast CE approval.
THIS IS
How I Support Your Success
01.
Clinical Strategy
I build a tailored clinical strategy to ensure your medical device is backed by strong clinical data, demonstrating its safety and performance – a critical step for CE approval.
02.
Clinical Evaluation Plan and Report
I craft a comprehensive Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER). These documents are crucial, showcasing your device’s compliance with regulatory standards.
03.
State-of-the-Art Report
Conducting an in-depth literature search according to MDCG guidances and the PRISMA method, I create a state-of-the-art report. This is a key component of your clinical strategy, providing essential context for your device in the medical field.
04.
Post-Market Clinical Follow-Up (PMCF)
I provide ongoing post-launch support with a Post-Market Clinical Follow-Up plan and report, ensuring your device maintains safety and performance standards compliance.
05.
Clinical Investigation Support
For your clinical investigations, I prepare a Clinical Investigation Protocol and an Investigator Brochure aligned with ISO 14155 and MDCG guidances. This includes careful planning and documentation, ensuring your clinical trials are conducted with the highest standards of accuracy and regulatory compliance.
THIS IS WHY
We Should Work Together
Always On Time
You can count on timely delivery and schedule adherence, ensuring no delays in your projects.
Visionary Collaboration
Your innovative device and my expertise create a powerful pathway to CE approval.
Time Efficiency
My approach simplifies the CE process, speeding up your product's path to market.
Personalized Approach
I customize my strategies to specifically suit your device's unique needs and goals.
Stress Reduction
Handling regulatory complexities becomes simpler, reducing your workload and worries.
Success Together
Let's join forces to turn your medical device into a healthcare market success story.
