ME

Mohammed ELSAEH — IDE & Q-Sub Consultant (Neurology/Orthopedic)

Scientific Researcher

A highly skilled Scientific Researcher with a Ph.D. in Automatic and Computer Science, specializing in the development of innovative robotic and virtual reality systems for medical applications. Possesses deep expertise in creating haptic control strategies for the rehabilitation of hemiplegic children, demonstrated through extensive postdoctoral research and publications. Proven ability in projec...

Experience: 13+ years

Expertise & Specializations

Regulatory Pathways

IDEQ-SubDe Novo

Device Specialties

NeurologyOrthopedicWearable Digital

Regions Served

Mohammed ELSAEH provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)

Credentials & Recognition

Education & Credentials

Possesses a strong academic foundation with a Ph.D. in Automatic and Computer Science from Université Polytechnique - Université de Valenciennes and a Master's degree in Software Engineering from the University of Bradford. This advanced education, focused on haptic control strategies and medical robotics, provides a deep technical understanding essential for developing and validating innovative SaMD and AI-driven medical devices. Their specialized knowledge in rehabilitation technologies makes them an invaluable asset for medtech companies creating complex therapeutic systems.

A recognized expert and thought leader in the field of virtual rehabilitation and medical robotics, evidenced by numerous publications in international refereed journals and presentations at prestigious international conferences. Their contribution to the field was formally acknowledged with a Best Poster Award at the Indo-French workshop on Robotics for Rehabilitation. This peer recognition highlights a credible and authoritative voice in the development of cutting-edge therapeutic technologies.

Certifications

Best Poster Award
Indo-French workshop on Robotics for Rehabilitation
2019

Professional Experience

A seasoned Scientific Researcher with extensive postdoctoral experience at a leading French polytechnic university, specializing in robotics and virtual reality for medical applications. Their career has centered on pioneering research, including developing decision-making algorithms and control strategies for the rehabilitation of hemiplegic children. This work, conducted in collaboration with clinical partners like the Marc Sautelet Rehabilitation Centre, demonstrates a strong ability to bridge advanced engineering with real-world clinical needs. This background is ideally suited for medtech companies in the R&D and clinical validation phases, particularly those developing novel neurological and orthopedic devices.

Executive Summary

Professional Overview

A highly skilled Scientific Researcher with a Ph.D. in Automatic and Computer Science, specializing in the development of innovative robotic and virtual reality systems for medical applications. Possesses deep expertise in creating haptic control strategies for the rehabilitation of hemiplegic child...

Core Specializations

Regulatory Pathways

IDEQ-SubDe Novo

Device Specialties

NeurologyOrthopedicWearable Digital

Services Offered

Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.

Cruxi Independent Snapshot

Best suited for

  • • MedTech companies seeking expert regulatory guidance

Experience signals

  • Regions: US, EU
  • Background: 13+ years of regulatory experience.

Cruxi view

With a 13-year background as a Scientific Researcher, Mohammed ELSAEH offers a rare and powerful combination of a Ph.D. in Computer Science and deep, hands-on expertise in developing robotic, AI, and VR systems for medical applications. He is an exceptional asset for companies creating novel Class II neurological and orthopedic devices, particularly SaMD. His strength is not in traditional submission authoring, but in the critical foundational work: architecting the robust test strategies and generating the high-integrity clinical and performance data essential for successful Q-Submission, IDE, and De Novo pathways. Mohammed's proven ability to bridge advanced R&D with real-world clinical needs makes him invaluable for translating innovative concepts into regulator-ready evidence packages.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

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