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It Started With a Patient I Couldn’t Help

As a resident in general surgery, I treated a young man after a car accident. He was left with total anal incontinence. The devices we had weren’t enough. We couldn’t give him his life back.

So instead of moving on, I decided to work on a solution.

That experience led to my first medical device, my thesis, and a Master’s in Medical Engineering in Grenoble, where I moved into research and development.

That’s where I realized something critical: a device can be excellent and still fail if the clinical evidence doesn’t hold up.

The Problem I Kept Running Into

For the past 10+ years, working on clinical evaluations for Class I to Class III devices , orthopedic, cardiovascular, neurology, dental, AI-based technologies , I spent hours every week searching for basic information.

Which Notified Bodies can certify this device class? What does the latest MDCG guidance say? Which companies make similar devices? Where are the FDA guidance documents for this product code? Who is the right expert to consult?

The information existed, but it was scattered across dozens of websites , FDA.gov, the European Commission NANDO database, individual Notified Body websites, regulatory agency portals, industry news sites. Each with different interfaces, different search systems, different update schedules.

I looked everywhere for a comprehensive, free platform that aggregated all of this. I could not find one.

So I built it.

What Medical Device Navigator Is Today

Medical Device Navigator is the most comprehensive free platform for medical device regulatory intelligence. Everything is aggregated in one place, searchable, and accessible to everyone , no paywall, no subscription, no hidden fees.

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4,975+ Companies

Medical device manufacturers worldwide with FDA establishment data, regulatory markets, and contact information.

5,064+ Devices

FDA-cleared and PMA-approved medical devices with classification, clearance data, product codes, and manufacturer details.

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53 EU Notified Bodies

Complete directory under MDR 2017/745 and IVDR 2017/746 with scope, designation status, and contact details.

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34 Competent Authorities

Regulatory agencies worldwide , FDA, ANSM, BfArM, MHRA, Swissmedic, Health Canada, TGA, PMDA, and more.

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1,129+ Resources & Guidelines

MDCG guidance, FDA guidances, clinical guidelines from 247 medical societies, and regulatory standards.

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43+ Experts

A growing directory of medical device professionals , regulatory affairs, clinical evaluation, quality assurance, medical writing, and more.

Free Forever , Here Is Why

Medical device regulation is complex enough. Access to regulatory intelligence should not be another barrier.

Whether you are a startup navigating your first CE marking, a regulatory affairs professional tracking MDCG updates, a clinical evaluation expert searching for equivalent devices, or a quality manager building your QMS , this platform is for you.

No paywall. No subscription tiers. No “contact sales for pricing.” The information is here because our industry needs it to be here, and it should be accessible to everyone.

Help Us Build It , For All of Us

Medical Device Navigator is a community project. It grows because professionals like you contribute to it.

  • Join the Experts Directory , Get listed and help others find the right expertise
  • Contribute content , Share your knowledge through articles, guides, or regulatory insights
  • Report errors , If you spot incorrect data, let us know so we can fix it
  • Spread the word , Share the platform with your colleagues and network
  • Give feedback , Tell us what is missing, what could be better, what you need

This platform exists because one person could not find what the industry needed. It will thrive because the community builds it together.

The Founder

Dr. Hatem Rabeh, MD, MSc Ing

Founder & Editor-in-Chief | Clinical Evaluation Expert

Dr. Hatem Rabeh is a Medical Doctor and Medical Engineer (MSc, Université Grenoble Alpes, France) with 10+ years of expertise in medical device clinical evaluation and regulatory affairs.

His career began in clinical practice (general surgery), where a patient case that conventional devices couldn’t solve led him to medical device development. He then moved into research at TIMC laboratory (Grenoble) and clinical evaluation at IMACTIS (now part of GE HealthCare), where he co-authored peer-reviewed publications on CT-Navigation systems for interventional radiology.

He has contributed to dozens of Clinical Evaluation Reports (CER) and State-of-the-Art (SOTA) reports across Class I to Class III devices , orthopedic, cardiovascular, neurology, dental, and AI-based technologies , supporting successful regulatory submissions under EU MDR.

Alongside his consulting work, he has built community resources used by thousands of professionals:

  • Medical Device Navigator , this platform
  • Article Selection Navigator , free tool to streamline literature review
  • Clinical Evaluation Navigator , newsletter and community for CE professionals

Connect:
LinkedIn |
ResearchGate |
Substack |
X / Twitter

Editorial Policy

Accuracy: All regulatory content is sourced from official publications (FDA, European Commission, MDCG, Swissmedic, MHRA, Health Canada). News articles cite primary sources.

Independence: Editorial content is independent. We do not accept payment for editorial coverage or directory listings.

Currency: Our databases are updated regularly. News coverage is published daily. Guidance documents are added as released.

Corrections: If you identify an error, please contact us. We are committed to correcting inaccuracies promptly.

Contact Us

General inquiries: contact@medicaldevicenavigator.com

Based in Grenoble, France | Serving the global medical device community

Join the Community

Whether you want to get listed as an expert, contribute content, or simply stay informed , there is a place for you here.

Browse the Experts Directory

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