…review boards (an independent committee of people that reviews research plans before research is conducted and once a year, at minimum, during the research). Further hindering patient participation is the…
…review boards (an independent committee of people that reviews research plans before research is conducted and once a year, at minimum, during the research). Further hindering patient participation is the…
Medical device cybersecurity is a looming threat that often appears in the news. Hear industry experts discuss design, oversight, risk mitigation and containment at the Medical Device Cybersecurity conference, March…
Medical device cybersecurity is a looming threat that often appears in the news. Hear industry experts discuss design, oversight, risk mitigation and containment at the Medical Device Cybersecurity conference, March…
…were to put up new military bases closer to the Philippines, or threaten to invade the Philippines, President Duterte would immediately call the United States to protect them. Besides the…
…were to put up new military bases closer to the Philippines, or threaten to invade the Philippines, President Duterte would immediately call the United States to protect them. Besides the…
…and new product introduction.” Gallisa states that regulatory compliance makes up “25-35% of the cost of [medical device] goods.” The National Association of Manufacturers agrees. In its 2014 report, “The…
…and new product introduction.” Gallisa states that regulatory compliance makes up “25-35% of the cost of [medical device] goods.” The National Association of Manufacturers agrees. In its 2014 report, “The…
As if things couldn’t get worse for Theranos, the news came today that the company is cutting nearly 41% of its positions (155 employees), with only 220 staff remaining. According…
As if things couldn’t get worse for Theranos, the news came today that the company is cutting nearly 41% of its positions (155 employees), with only 220 staff remaining. According…
The latest rumors following FDA Commissioner Robert Califf, M.D.’s interview with The Washington Post, is that he may leave FDA under President-elect Donald Trump’s administration. Califf said that Trump’s transition…
The latest rumors following FDA Commissioner Robert Califf, M.D.’s interview with The Washington Post, is that he may leave FDA under President-elect Donald Trump’s administration. Califf said that Trump’s transition…
…consolidation continues Slow pricing growth due to GPOs, value analysis committees and other buying committees R&D remains strong, with device manufacturers spending about 7% of revenue to fund research Cybersecurity…
…consolidation continues Slow pricing growth due to GPOs, value analysis committees and other buying committees R&D remains strong, with device manufacturers spending about 7% of revenue to fund research Cybersecurity…
…the confusion that often ensues among healthcare providers and patients, CDRH has changed how it communicates device recalls. As of January 3, the center is posting recall information right when…
…the confusion that often ensues among healthcare providers and patients, CDRH has changed how it communicates device recalls. As of January 3, the center is posting recall information right when…
…today is highly sophisticated, feature-rich and has a combination of advanced electronics and software, making it increasingly complex. Thus, any operational or functional failure of such medical equipment can be…
…today is highly sophisticated, feature-rich and has a combination of advanced electronics and software, making it increasingly complex. Thus, any operational or functional failure of such medical equipment can be…
…topics include IDE submissions, and new or revised procedural guidances for MDUFA IV implementation. FDA’s B-list of final guidance documents include: UDI: Direct Marking of Devices Evaluation and Reporting of…
…topics include IDE submissions, and new or revised procedural guidances for MDUFA IV implementation. FDA’s B-list of final guidance documents include: UDI: Direct Marking of Devices Evaluation and Reporting of…
