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Watchdog
Compliance Guides
Expert guidance on medical device regulations, complaint processes, and compliance requirements for MDR and FDA.
intermediate
• 10 min read
How to Submit a Claim for a Medical Device to the FDA
Step-by-step guide for reporting non-compliant medical devices to the U.S. Food and Drug Administration
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advanced
• 15 min read
Consequences of Not Complying with Medical Device Regulations
Understanding the legal, financial, and criminal penalties for MDR non-compliance under Articles 92, 94, and 95
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intermediate
• 12 min read
How to Present a Formal Complaint Against a Medical Device Manufacturer in Europe
Comprehensive guide on filing MDR complaints with European regulatory authorities for non-compliant medical devices
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