Complaint Processing Draws FDA Scrutiny

It's easy to understand the problem. You must cross every "t" and dot every "i," creating systems that integrate data collection, complaint evaluation and risk assessment, as well as processes that determine how complaints are categorized and whether they are valid.

And further complications exist. Multinational companies, for instance, must consider how to share complaint information across divisions or product lines.

But, FDAnews has just released a new management report written especially to help device manufacturers avoid warning letters and other FDA sanctions — by spelling out in plain English the do's and don'ts of effective device complaint management.

Medical Device Complaint Management: A Guide for Compliance provides a complete explanation to help you comply with FDA requirements, including:

• How to evaluate each complaint to determine if a Medical Device Report (MDR) is required
• What service people should be watching for, to identify complaints when interacting with consumers
• Training the sales force to recognize and report complaints
• Key terms, definitions and forms you are responsible for when submitting MDRs
• Which staffers are qualified to make medical judgments, and who the FDA will deem appropriate
• Distinguishing between corrections and removals
• Defining key terms — "market withdrawal," "routine servicing," "stock recoveries" and others
• When a report is required for a correction or removal, and which documents must be kept on file in event of a report filing
• And much more

Order Today
It's certain that FDA's inspectors will examine your complaint management reporting systems on their next visit. Now is the time to start whipping your systems into shape. Don't delay. Order Medical Device Complaint Management: A Guide for Compliance today.

The report is written especially for professionals working in:

• Quality
• Manufacturing
• Engineering
• Regulatory affairs professionals 
• Legal
• Compliance officers 
• Consultants/service providers
• Legal

Buy Now
Medical Device Complaint Management: A Guide for Compliance is available in print or PDF format for $397. Act now: place your order here. (Add $10 shipping and handling per book for printed books shipped to the U.S. and Canada, or $35 per book for books shipped elsewhere. Virginia residents, please add 5 percent sales tax.)

Satisfaction Guaranteed
Your purchase is 100% guaranteed. If for any reason you decide the report is not for you, simply return the undamaged hard copy within 30 days of purchase and you'll receive a full refund (less shipping/handling). For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase to receive a refund.

Four Easy Ways to Order
Please mention priority code 11408 when ordering.
1. Order online.
2. Call toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600. Use your American Express, Visa or MasterCard.
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4. Mail your check to: FDAnews, 300 N. Washington St., Suite 200, Falls Church, VA 22046-3431