Safeguards must be implemented to protect patients
A true understanding of workflow allows more pointed questions to improve performance
Respondents say regulatory systems and fragmented patient care are difficult hurdles
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
Four myths surrounding hosting providers
Lessening the workload is proving to diminish waste
A new report suggests that the United States does not
The agency is holding medical device manufacturers accountable for eMDRs and CAPAs
The rules are changing
Simplify auditing and amplify innovation
Four teams receive seed funding for concepts created during a weekend
Rapid growth in the use of bio materials drives 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
Temp employees need to be held to the same training rigor as full-time staff
New interface provides access to FDA database of medical device reports
Consider the human factor