The draft provides suggestions on device design, labeling and documentation that should be included in premarket submissions.
The Healthcare Supply Chain Association releases a laundry list of areas in which device companies and providers must increase security of devices and networks.
PwC’s Health Research Institute releases its annual Top Health Issues report.
The healthcare ecosystem needs to be more proactive in managing cybersecurity risks.
As software becomes more complex and connected, device manufacturers must address more risks.
The healthcare industry has a new set of threats on its hands.
The last decade has brought more interaction between the device industry and FDA related to conducting health hazard evaluations, but companies continue to face obstacles.
From ensuring patient safety to protecting a company’s reputation, the product recall process starts with putting together the right team of qualified individuals.