Don’t start with what the device does; start with who it’s for
How the program alignment, case for quality, and transparency initiatives help healthcare
Creating a simpler chocolate bar requires some complicated planning
Three free passes for medical device data systems
Lessening the workload is proving to diminish waste
The agency is holding medical device manufacturers accountable for eMDRs and CAPAs
The rules are changing
Simplify auditing and amplify innovation
Comment on FDA's proposed amendments to the Food Safety Modernization Act
Compliance is determined by a review of all required documentation, including risk management
New interface provides access to FDA database of medical device reports
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