Hatem Rabeh, Md, Msc Ing Email and Phone Number
Hey there, thanks for stopping by my profile!I'm Dr. Hatem Rabeh, blending the roles of a medical doctor and medical engineer with over 8 years of experience in the medical device sector. My specializations include clinical evaluation and clinical investigations for medical devices.My journey into this field was anything but conventional. It all began during my days as a medical doctor in general surgery. I encountered a case that profoundly impacted my career path: a young patient suffering from total anal incontinence due to a tragic car accident. The limitations of existing medical interventions for his condition sparked a deep interest in me. This led to my thesis on anal and urinary incontinence and the creation of a new medical device, marking my foray into the world of medical devices.Furthering my expertise, I pursued a Master of Science in Medical Engineering at Grenoble, immersing myself in groundbreaking research and development at TIMC, a leading laboratory in medical engineering. This experience solidified my knowledge and passion for developing innovative medical devices.Transitioning from academia, I contributed significantly to the clinical strategy of several startups, leading to successful acquisitions and demonstrating the impact of my work on their clinical evaluations and trials. Now, as a freelancer, I am committed to helping more startups navigate the complexities of clinical evaluation, clinical investigation, and PMCF for their innovative medical devices.I am also deeply committed to sharing my knowledge and insights in the field. I regularly publish insightful information on clinical evaluation and clinical trials for medical devices.These publications are a part of my ongoing effort to inform and educate the community, ensuring that the latest developments and best practices in the field are accessible to all.Furthermore, I've created the 'Article Selection Navigator,' a tool designed to accelerate the literature search process. This tool is my contribution to the community, available for free, underscoring my commitment to supporting our collective advancement in medical device development.If you're considering a collaboration or seeking advice on clinical strategy for your medical devices, don't hesitate to reach out. My virtual door (and coffee machine) is always open.A little extra: Besides my medical and engineering credentials, I'm also a clinical data scientist, continuously exploring the intersection of healthcare and data.Thanks for making it this far in my story. You're awesome!Best,Hatem Rabeh
Clinical Evaluation Navigator
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Freelance Medical WriterClinical Evaluation Navigator Feb 2024 - PresentAs a Freelancer, I focus on simplifying the complexities of Medical Device Regulation (MDR) for you. With my unique, tested method, I expedite the creation and approval of your clinical documentation, paving a quicker path to CE marking. Imagine reducing compliance burdens and enhancing your product's development cycle. Let's discuss how my approach can transform your medical device's pathway, converting challenges into clear opportunities: - MDR-Aligned Clinical Strategy Development: Partnering with you to develop a clinical strategy that eases the CE approval process. I understand that each device is unique, and my strategies are customized to integrate your product's specific needs with MDR requirements, paving a clear path to market.- Clinical Evaluation Plan and Report: Crafting Clinical Evaluation Plans (CEPs) and Reports (CERs) for medical devices across all classes, focusing on your product's specific characteristics. My expertise ensures your documentation is robust and compliant and effectively communicates the safety and efficacy of your device as per MDR standards.- Targeted Literature Search and State-of-the-Art Reports: Conducting literature searches and compiling state-of-the-art reports that are compliant and insightful for your product development. This helps benchmark your device against current market standards, a crucial step in MDR compliance.- Customized Post-Market Clinical Follow-Up (PMCF) Plans and Reports: Designing PMCF plans and creating PMCF reports that align with your device's post-market performance and safety monitoring needs, ensuring ongoing MDR compliance and supporting the continual improvement of your product.- Clinical Protocol and Investigator Brochure Development Tailored to Your Device: Creating clinical trial protocols and investigator brochures that resonate with your device's unique aspects ensures that all clinical trials are conducted ethically, scientifically, and in line with MDR regulations.
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Clinical Evaluation SpecialistEcential Robotics Oct 2020 - Feb 2024Gières (Grenoble), Auvergne-Rhône-Alpes, France, FrClinical evaluation, PMS, PSUR, and PMCF expert (writing, reviewing, and approving)Carrying out literature research Drafting the 510K report -
Clinical ScientistImactis Jul 2019 - Oct 2020Grenoble, France, FrClinical evaluation, PMS, PSUR and PMCF expert (writing, reviewing, and approving) Medical device reimbursement expert ( establishing the reimbursement strategy and creating related reports)Provide clinical and technical support to conduct clinical trials and to write medical articles & clinical publications.Develop and maintain a local and global KOL networkProvide Quality & regulatory engineering support in the development and manufacturing of new and existing medical devices (CE and FDA) -
Quality Management And Regulatory Affairs EngineerImactis Aug 2018 - Jul 2019Grenoble, France, FrProvide Quality & regulatory affairs engineering support in the development and manufacturing of new and existing medical devices (CE and FDA)Writing the clinical evaluation report, the PMCF, and the PSUR reportsImplementing the clinical evaluation process in the QMS
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Trainee Engineer In Quality Management And Regulatory AffairsImactis Feb 2018 - Jul 2018Grenoble, France, FrCarrying out the clinical evaluation according to the MEDDEV 2.7 / 1 rev4 recommendations and the new EU regulation 2017/745
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Medical Doctor & ResearcherTim Laboratory Of Technology And Medical Imaging Dec 2016 - Aug 2017Development of a wireless active implant (RECTEK)
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Medical Doctor In The Teaching Hospital Of MonasitrFaculté De Médecine De Monastir Nov 2014 - Nov 2016medical doctor in : Neurosurgery departmentCommunity and Preventive Therapy departmentPediatrics and Neonatology departmentPumonology departmentGynecological Obstetric departmentGeneral Surgery department
Hatem Rabeh, Md, Msc Ing Education Details
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Université Grenoble AlpesEngineering -
Harvard OnlineInformatics
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Université De MonastirMedicine
Frequently Asked Questions about Hatem Rabeh, Md, Msc Ing
What company does Hatem Rabeh, Md, Msc Ing work for?
Hatem Rabeh, Md, Msc Ing works for Clinical Evaluation Navigator
What is Hatem Rabeh, Md, Msc Ing's role at the current company?
Hatem Rabeh, Md, Msc Ing's current role is Clinical Evaluation Expert | I help you create your clinical strategy and accelerate your Clinical Evaluation process for your medical device. Contact Me 👇.
What schools did Hatem Rabeh, Md, Msc Ing attend?
Hatem Rabeh, Md, Msc Ing attended Université Grenoble Alpes, Harvard Online, Université De Monastir.
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