Consider the human factor
Administration cites low risk to patient safety
How validating potential software can ensure the best purchase decision
Joining forces to strengthen regulatory systems globally
Four programs speed innovative treatments to market
Chances are it is, despite what some Notified Bodies have declared
Visibility outside the four walls
DNA barcodes are improving the quality of the fish we eat
What the regulations lack in length they make up in complexity
Too much stick, not enough carrot?
Guidance describes framework and process of voluntary CDRH qualification
IAF announces the largest technical trade agreement ever prepared for the medical device standard
Outlook is cloudy with a chance of inspected meatballs
Compliance doesn’t have to be difficult
FDA increases inspections of compounding pharmacies
Improving patient care by ensuring medical devices work well together
FMSA includes enhanced focus on supply chain standards
FDA’s Office of Criminal Investigation steps in
Challenges and advantages for implementation
CDRH inspections account for 10–12 percent of all FDA inspections
