If a user discovers a deficiency in a device prior to use, does it have to be reported in the EU? How about the US? In the EU, do you need to report adverse events to the competent authority where the event occurred, where the device was made, or both? If an adverse event takes place involving a medical device made in the US, but the device is not available for sale in the US, must it be reported to the FDA?

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

Do you prepare your medical device facility for an FDA inspection the same way you did last year — or even six months ago? If you do, you could be in big trouble. The rules of the game have changed and the FDA is cracking down harder than ever before … and it’s only going to get worse.

Wondering what would improve your device company’s CAPA performance? We have answers from an exclusive, new FDAnews survey of devicemakers.

Just because a program or an app is running on an unregulated phone or tablet doesn’t mean that the app itself isn’t a medical device in the FDA's eyes. Like it or not, the FDA has made that clear. What’s not so clear? Where the agency draws the line between unregulated products and those the FDA must approve. Until now.

When is reporting voluntary vs. mandatory? What characteristics of the recall must you consider when making that determination? When there is a conflict, which rule applies? Discover the answers — and more — in a new management report from FDAnews.

Despite years of harmonization talks, the EU and US still follow very different marketing approval processes for medical devices. And when the EU’s MDD went into effect in 2010, those differences became more pronounced. Failing to know the differences could critically handicap your time to market and ability to operate efficiently. Failing to comply with those differences could shut you out of EU markets completely.

From FDAnews (published by Euromed Communications), this loose-leaf manual shows you how to satisfy all European regulations affecting your medical devices. You’ll find clear, practical and up-to-date guidance for every class of medical device and at every stage in the product life cycle, from selecting your conformity assessment route to registering with a competent authority and complying with global harmonization.

Negotiating an FDA Import Hold Crisis: Strategies for Challenging FDA Findings, a management report from FDAnews, maps out every aspect of an import hold, including how to fix problems before they land your shipment in trouble with FDA and customs officials, the best way to train your team to use the right (and avoid the wrong) approaches with FDA personnel and when to activate a rapid-response strategy that gets your imports off hold and into use fast.

Order your Nine-Volume Title 21 CFR Set today! The federal government has just compiled the new Nine-Volume Title 21 CFR Set for 2013 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2013.

At its heart, our industry is about saving and improving lives. That’s what draws people into this business in the first place. But sometimes people need reminding about that. That’s what this classic training DVDs has been doing for years, with powerful stories that remind people exactly how GMP compliance affects real life.

Now, your risk assessment team can learn today’s best strategies for designing and coordinating safety studies that deliver reliable data efficiently. In this book, two world-renowned authorities connect you with practical tips from real-world experts and former FDA officials. Reaching beyond what’s available in regulations or guidelines, here’s the know-how to prevent delays and “do-overs” and give your program the absolute best chance for success. Available in print or CD-ROM format.

Orphan Drugs in Asia: Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market is the research report that tells you how to obtain orphan drug status for products in Asian countries and the benefits that go along with it. This invaluable guide to Asia reviews orphan drug regulations across the continent and discusses crucial business issues unique to that part of the world. All this and more from Ames Gross and John Minot of Pacific Bridge Medical, the consulting firm that has provided more than 200 companies with regulatory information and business strategies to develop Asian markets.

Under the latest PDUFA, the FDA has five new criteria for choosing facilities to inspect – are you more likely to be inspected? Do your plans for dealing with drug shortages satisfy the new PDUFA requirements? How about your supplier quality agreements? Your facility registration? Your fast-track NDA? Your . . .

With Perfecting Your Company Core Data Sheets: A Guide for Authoring and Updating the CCDS, you'll have the tools to create and maintain a CCDS that will withstand regulatory scrutiny, and you’ll avoid the unnecessary extra work that comes from assuming what’s the best way to write them.