Postmarket Safety

How to Detect Trends in Medical Device Complaints

Some devicemakers can be slow to recognize trends in medical device complaints. It’s not enough to have a solid complaint handling system when regulators expect you to learn something from the feedback you receive. Read More

Medical Device Security is Deeply Lacking, Says New Study

Two-thirds of medical devicemakers and about half of healthcare delivery organizations believe a cyber attack on a medical device built or in use by their organizations is likely to occur during the next year — and only 17 percent of those devicemakers and 15 percent of those healthcare organizations are taking significant steps to prevent such attacks. Read More