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MD
Watchdog

Medical Device

Watchdog

Protecting patients by ensuring medical devices comply with MDR and FDA regulations through community-driven oversight

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Key Features

Regulatory Compliance

We ensure medical devices meet MDR and FDA regulations through thorough investigation and documentation.

Report Violations

Submit potential regulatory violations anonymously. Our experts review and file formal complaints.

Professional Review

Quality management and regulatory professionals volunteer to study cases and prepare legal documentation.

Community Driven

A collaborative effort by independent professionals committed to patient safety and market compliance.

Anonymous Reporting

Your identity remains protected. MD Watchdog presents complaints on behalf of the community.

Legal Expertise

Formal complaints prepared according to MDR Article 93 and FDA reporting requirements.

247+
Companies Investigated
89
Complaints Filed
34
Regulatory Actions
100%
Anonymous Reports

Keeping the Market Safe and Compliant

MD Watchdog is a collaborative initiative by quality management and regulatory professionals dedicated to ensuring medical devices meet safety standards

Regulatory Compliance

We ensure medical devices meet MDR and FDA regulations through thorough investigation and documentation.

Report Violations

Submit potential regulatory violations anonymously. Our experts review and file formal complaints.

Professional Review

Quality management and regulatory professionals volunteer to study cases and prepare legal documentation.

Community Driven

A collaborative effort by independent professionals committed to patient safety and market compliance.

Anonymous Reporting

Your identity remains protected. MD Watchdog presents complaints on behalf of the community.

Legal Expertise

Formal complaints prepared according to MDR Article 93 and FDA reporting requirements.

How MD Watchdog Works

A transparent process ensuring thorough investigation and proper regulatory filing

1

Submit Report

Report a potentially non-compliant medical device through our secure form

2

Expert Review

Volunteer professionals review the submission and gather evidence

3

Documentation

Formal complaint prepared according to MDR/FDA requirements

4

Official Filing

Complaint submitted to relevant regulatory authorities

Recent Investigations

Recent cases of medical devices found to be non-compliant with regulations

EU MDR Class 3

AI Dermatologists App

Diagnostic app lacking proper certification, IFU, and fraudulent CE marking claims

Read Full Complaint →
FDA Class 2

Example Device 2

Medical device operating without FDA clearance in the United States market

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BOTH Class 2b

Example Device 3

Device with missing documentation and improper risk classification

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Help Keep Patients Safe

If you've identified a medical device that may not comply with MDR or FDA regulations, report it anonymously. Our team of volunteer professionals will investigate and file formal complaints with regulatory authorities.

About MD Watchdog

MD Watchdog is a volunteer initiative by independent quality management and regulatory professionals united by the goal of keeping the medical device market safe and compliant.

We study potential violations, prepare formal complaints, and submit them to regulatory authorities without compensation. This project is funded by private sponsors who share our commitment to patient safety.

By presenting complaints on behalf of the community, we protect individual reporters while ensuring regulatory bodies receive comprehensive, professionally prepared documentation of potential violations.

Learn More About Our Mission →