Beginning today, FDA will choose up to nine applicants for a new Voluntary Medical Device Manufacturing and Product Quality Pilot Program. “The FDA believes that proactive engagement with medical device…
Beginning today, FDA will choose up to nine applicants for a new Voluntary Medical Device Manufacturing and Product Quality Pilot Program. “The FDA believes that proactive engagement with medical device…
FDA’s Office of Regulatory Affairs has released the most frequently cited inspectional observations for fiscal year 2017. Lack of or inadequate procedures related to DHRs, calibration and inspection, process control,…
FDA’s Office of Regulatory Affairs has released the most frequently cited inspectional observations for fiscal year 2017. Lack of or inadequate procedures related to DHRs, calibration and inspection, process control,…
Today Zimmer Biomet announced the appointment of Bryan C. Hanson as the company’s president and CEO. Hanson was most recently a member of Medtronic’s executive committee and the executive vice…
Today Zimmer Biomet announced the appointment of Bryan C. Hanson as the company’s president and CEO. Hanson was most recently a member of Medtronic’s executive committee and the executive vice…
Last week CDRH posted a list of the guidance documents it plans to issue in FY 2018. Prioritized by an A and B list, final guidance priorities include a UDI…
Last week CDRH posted a list of the guidance documents it plans to issue in FY 2018. Prioritized by an A and B list, final guidance priorities include a UDI…
From learning how to plan for FDA submissions to real-world tools to manage risk to addressing critical cybersecurity challenges, MedTech Intelligence has several practical workshops and conferences for the first…
From learning how to plan for FDA submissions to real-world tools to manage risk to addressing critical cybersecurity challenges, MedTech Intelligence has several practical workshops and conferences for the first…
The new administration has been in place for almost a year, but many questions remain unanswered. As health reform continues to be a big concern, 2018 “will be distinguished by…
The new administration has been in place for almost a year, but many questions remain unanswered. As health reform continues to be a big concern, 2018 “will be distinguished by…
Coming off a very strong 2017, Edwards Lifesciences, Inc. has big plans for next year, as it will continue on its path to investing in breakthrough technologies and projects global…
Coming off a very strong 2017, Edwards Lifesciences, Inc. has big plans for next year, as it will continue on its path to investing in breakthrough technologies and projects global…
…who has been doing business in Asia for 35 years, I have to disagree. My discussions with Asian executives and the news that I read during my trip echoed my…
…who has been doing business in Asia for 35 years, I have to disagree. My discussions with Asian executives and the news that I read during my trip echoed my…
This year cybersecurity and ransomware have been a significant issue across all industries. Now ECRI is alerting the healthcare industry to the potential danger that ransomware and malware pose to…
This year cybersecurity and ransomware have been a significant issue across all industries. Now ECRI is alerting the healthcare industry to the potential danger that ransomware and malware pose to…
…market grew by 44 percent in 2016, report says,” MobiHealthNews, February 8, 2017. Regaldo, Antonio. “This Doctor Diagnosed His Own Cancer with an iPhone Ultrasound,” MIT Technology Review, October 27,…
…market grew by 44 percent in 2016, report says,” MobiHealthNews, February 8, 2017. Regaldo, Antonio. “This Doctor Diagnosed His Own Cancer with an iPhone Ultrasound,” MIT Technology Review, October 27,…
