FDA defines some terms
A Case for Quality is changing medical device manufacturers focus and FDA’s approach
An industry study recommends five changes for intercenter consultations
The Office for Civil Rights has audits planned for next year
Tools that make analysis easier
Safeguards must be implemented to protect patients
The 21st Century Cures Act improves the regulatory process
Why not to abandon the last line of defense for patient safety?
It’s a brave new world of electronic consent
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
