This thorough overview of FDA medical device enforcement trends reveals what triggered 2011 warning letters, and where investigators will be training their sites in the months ahead.

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

Just released from FDAnews — Investigations Operations Manual 2012 — the FDA’s own internal guidance on how to inspect a drug or device company.

Order your Two-Volume Devices/Diagnostics Title 21 CFR Set today! The federal government has just compiled the new devices/diagnostics-related Title 21 CFR volumes for 2012 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2012.

Order your Nine-Volume Title 21 CFR Set today! The federal government has just compiled the new Nine-Volume Title 21 CFR Set for 2012 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2012.

Order your Two-Volume Clinical Trials Title 21 CFR Set for Devices today! The federal government has just compiled the new clinical trial-related Title 21 CFR volumes for devices for 2012 with all of the FDA rules for devices updated through April 1, 2012.

Order your Three-Volume Clinical Trials Title 21 CFR Sets today! The federal government has just compiled the new clinical trial-related Title 21 CFR volumes for 2012 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2012.

Order your individual Title 21 CFRs today! The federal government has just compiled the new Title 21 CFRs for 2012 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2012.

In medical device manufacturing, success means staying abreast of regulatory changes from Asia to Argentina ... and beyond. Impossible? Not at all.

No question about it: social media presents a host of problems for drug and device companies. Still, for brands that manage their presence successfully, the upside potential is huge. But what’s the secret to keeping control over your brand as people share on social media? What does an FDA-proof social media presence look like? What happens if consumers use YouTube, Twitter or Facebook to report previously unknown adverse events? How do you present balanced promotions and important safety information using social media? Here’s how to develop a social media strategy that keeps you compliant and competitive.

The FDA originally videotaped these 10 training sessions — more than eight hours’ worth — to train its own staff in quality training. Now FDAnews has brought all 10 sessions together on one convenient, affordable DVD, designed to give you the kind of high-level employee education everyone wants … with the flexibility that makes in-house training most beneficial.

Whether you’re new to the quality profession or you’re a veteran looking to strengthen CAPA processes in today’s tougher enforcement climate, Principles of an Effective CAPA System: A Guide for Device and Drug Companies plugs you into best practices that help you avoid the investigation, documentation and corrective action mistakes that have landed so many other companies with warning letters.

As a clinical trial sponsor negotiating a trial budget, you need to clearly understand what costs are billable to third-party payers, including Medicare, before you sign contracts. Failure to properly address this can result in budget problems, inadequate liability coverage, or even fines and other penalties. Here’s how to avoid Medicare billing problems in your clinical trials: Billing Medicare for Clinical Trials Costs: Avoiding Noncompliance and Budgeting Accurately

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

Step-by-step, this report helps you master the many aspects of change control and the many regulations that must be factored into emergency decision-making and routine company procedures.