About MD Watchdog
Protecting patients by ensuring medical device regulatory compliance
Our Mission
MD Watchdog is a volunteer-driven initiative dedicated to protecting patients from non-compliant medical devices. We bridge the gap between concerned healthcare professionals, patients, and regulatory authorities by providing a secure, anonymous platform for reporting regulatory violations.
What We Do
Anonymous Reporting
We provide a secure platform for healthcare professionals and patients to report medical device violations without fear of retaliation.
Expert Review
Our team of volunteer regulatory professionals reviews each submission to ensure accuracy and compliance with MDR and FDA requirements.
Official Filing
We file formal complaints with appropriate regulatory authorities including European MDR bodies and the FDA.
Why This Matters
Medical devices classified as Class III and Class IIb have the potential to cause serious harm or death if they fail to meet regulatory standards. Despite strict regulations like EU MDR 2017/745 and FDA requirements, many devices continue to operate without proper certification.
Non-compliant devices may lack:
- Proper clinical evaluation and evidence
- Essential safety documentation (Instructions for Use)
- Valid CE marking or FDA clearance
- Unique Device Identification (UDI) registration
- Post-market surveillance systems
Every report we file could prevent patient harm and save lives.
Our Team
Volunteer Professionals
MD Watchdog is operated by a dedicated team of volunteers with expertise in:
- Medical Device Regulation (MDR 2017/745)
- FDA compliance and 510(k) processes
- Clinical evaluation and risk management
- Quality Management Systems (ISO 13485)
- Post-market surveillance
- Technical documentation review
- Regulatory affairs consulting
- Healthcare law and patient advocacy
Our Impact
Get Involved
Whether you're a healthcare professional, regulatory expert, or concerned citizen, you can help protect patients from non-compliant medical devices.
Legal Notice
MD Watchdog operates as an independent, volunteer-based initiative. We are not affiliated with any regulatory authority, medical device manufacturer, or healthcare institution. All reports are based on publicly available information and submitted evidence. We maintain strict confidentiality and anonymity for all reporters in accordance with applicable data protection laws.