How to Avoid an MDR Disaster: Setting up an Effective MDR Reporting System

Held July 22, 2008

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.

This audio CD/Transcript is a must for anyone entrusted to keep their device or diagnostics firm in compliance, including:
  • Auditors
  • Compliance officers
  • Consultants/service providers
  • Data management and statistics personnel
  • Executive management
  • General/corporate counsel
  • Investigators
  • Managers
  • Personnel new to the industry
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Scientists/engineers
  • Training personnel
  • Validation specialist

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Pamela Furman is a partner in King & Spalding's FDA/Healthcare Practice Group. She joined the firm in 2007, bringing with her more than 12 years of experience in advising clients on a broad range of FDA regulatory issues. Pamela’s practice focuses on FDA medical device matters, including premarket notification, premarket approval, product recalls, Medical Device Reporting (MDR), Quality System Regulation (QSR) compliance, establishment registration and device listing, labeling and promotion, reclassification, import/export issues, and investigational device exemption (IDE) requirements. 

Pamela graduated summa cum laude, Phi Beta Kappa, from Yale University in 1988 with a Bachelor of Arts in political science and received her law degree from Stanford University in 1994. She is an active member of the American Health Lawyers Association (AHLA) and currently serves on the editorial board of AHLA's Journal of Health and Life Sciences Law.

Order now!