…providers to ensure patient safety even when healthcare personnel are not present. There are many different automated patient monitoring systems in development today. For example, researchers have applied AI computer…
…providers to ensure patient safety even when healthcare personnel are not present. There are many different automated patient monitoring systems in development today. For example, researchers have applied AI computer…
Companies must show that their software systems are performing as expected to comply with regulatory requirements. All validation activities and test results must be documented to define both how the…
Companies must show that their software systems are performing as expected to comply with regulatory requirements. All validation activities and test results must be documented to define both how the…
…people’s questions about participating in clinical trials or reporting adverse events. Digital or computerized ‘twins’ of patients can be used to model a medical intervention and provide biofeedback before patients…
…people’s questions about participating in clinical trials or reporting adverse events. Digital or computerized ‘twins’ of patients can be used to model a medical intervention and provide biofeedback before patients…
…performed remotely, but all subjects must be given a contact for answers to pertinent questions about the research and research subjects’ rights as well as whom to contact in the…
…performed remotely, but all subjects must be given a contact for answers to pertinent questions about the research and research subjects’ rights as well as whom to contact in the…
…more complex information and highlight critical safety information. But, of course, it is not always possible to communicate all facets of intended use via design affordances, especially for more complex…
…more complex information and highlight critical safety information. But, of course, it is not always possible to communicate all facets of intended use via design affordances, especially for more complex…
…neurovascular, the most common device used is a coil, where you can go in and choke off in aneurysm or a tumor, and there are a lot of small components…
…neurovascular, the most common device used is a coil, where you can go in and choke off in aneurysm or a tumor, and there are a lot of small components…
…long run. References: [1] DIHK (2022). Gesundheitswirtschaft unter Druck. https://www.dihk.de/resource/blob/73350/4912206cdf7717fd3e770a3927f58537/gesundheitsreport-fruehsommer-2022-data.pdf [2] Obelis Group (2022): What are the effects of the implementation of MDR on the EU medical device market? https://www.obelis.net/news/what-are-the-effects-of-the-implementation-of-mdr-on-the-eu-medical-device-market/…
…long run. References: [1] DIHK (2022). Gesundheitswirtschaft unter Druck. https://www.dihk.de/resource/blob/73350/4912206cdf7717fd3e770a3927f58537/gesundheitsreport-fruehsommer-2022-data.pdf [2] Obelis Group (2022): What are the effects of the implementation of MDR on the EU medical device market? https://www.obelis.net/news/what-are-the-effects-of-the-implementation-of-mdr-on-the-eu-medical-device-market/…
On the heels of the EPA’s announcement of two new proposed rules to reduce ethylene oxide (EtO) emissions, Jeff Shuren, M.D., J.D., director of the FDA CDRH, announced a radiation…
On the heels of the EPA’s announcement of two new proposed rules to reduce ethylene oxide (EtO) emissions, Jeff Shuren, M.D., J.D., director of the FDA CDRH, announced a radiation…
The UK MHRA has published “Software and Artificial Intelligence as a Medical Device.” The guidance document assembles previous guidances and regulatory requirements for SaMD and AIaMD devices seeking commercialization in…
The UK MHRA has published “Software and Artificial Intelligence as a Medical Device.” The guidance document assembles previous guidances and regulatory requirements for SaMD and AIaMD devices seeking commercialization in…
…general insights regarding off-label use. Competitor Activity – continuous tracking. The constant tracking of competitor and similar product performance not only makes good commercial sense, it provides fresh data for…
…general insights regarding off-label use. Competitor Activity – continuous tracking. The constant tracking of competitor and similar product performance not only makes good commercial sense, it provides fresh data for…
