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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
Australia’s Therapeutic Goods Administration will likely follow the FDA’s lead and the International Medical Device Regulators Forum’s model for regulating software for medical devices. Read More
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