How to Avoid an MDR Disaster: Setting up an Effective MDR Reporting System
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Congress and public interest groups have hammered the FDA’s scrutiny of postmarket surveillance and the agency has responded. Now, Medical Device Reporting (MDR) systems are often the first place the FDA targets during an inspection. Non-compliance is taken as an indication of a facility operating outside a state of control and a sign of larger problems to come.
The device and diagnostic industry has been caught unaware, and warning letters for insufficient MDR systems are on the rise. Just this year, a firm was warned for not reporting that its UV phototherapy systems were blamed for burning patients. Another was cited for not establishing quality system measures — it had no MDR procedures at all.
What can you do to avoid getting warning letters and the bad press that follows?
Attorney Pamela Furman will teach you about the MDR regulatory framework, the penalties of noncompliance, pitfalls to avoid and the significant keys to success.
Order today to listen in and discover:
- Tips to avoid common defects in complaint-handling systems that can lead to MDR noncompliance
- Recommendations for crafting effective written MDR procedures
- Strategies to avoid common MDR mistakes, such as late reporting and inconsistent reporting
- Recommendations on how to successfully complete MDR forms
- Consequences of failing to comply with MDR requirements
- The impact of recent MDR-related statutory changes
Learn how to avoid warning letters and the negative press attention that follows.