…about the prevalence of cybersecurity threats in medical devices. The fact that cybersecurity worries have now entered the medical device world shouldn’t come as too much of a surprise. In…
…about the prevalence of cybersecurity threats in medical devices. The fact that cybersecurity worries have now entered the medical device world shouldn’t come as too much of a surprise. In…
…(i.e., grasping). It is not far from robotic gloves to exoskeletons that promise even greater benefits in mobilization therapy. FreeBionics, for instance, is hoping that its Free Walk system will…
…(i.e., grasping). It is not far from robotic gloves to exoskeletons that promise even greater benefits in mobilization therapy. FreeBionics, for instance, is hoping that its Free Walk system will…
…information on all aspect of FDA regulation of devices. Several years ago MedTech Intelligence compiled a basic list of non-commercial regulatory reference links, most from the FDA itself, which were…
…information on all aspect of FDA regulation of devices. Several years ago MedTech Intelligence compiled a basic list of non-commercial regulatory reference links, most from the FDA itself, which were…
…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2017, September). FDA.gov Website. Retrieved October 06, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm575367.htm…
…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2017, September). FDA.gov Website. Retrieved October 06, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm575367.htm…
…the hospital of the future model provides not only the best care when needed but the best care before it is needed, all while including the patient from the onset….
…the hospital of the future model provides not only the best care when needed but the best care before it is needed, all while including the patient from the onset….
…undergo rapid aging. According to a 2016 study in the Journal of Internal Medicine, Alzheimer’s Disease (AD) is the most common neurodegenerative disorder in Asia and comprises of over 60%…
…undergo rapid aging. According to a 2016 study in the Journal of Internal Medicine, Alzheimer’s Disease (AD) is the most common neurodegenerative disorder in Asia and comprises of over 60%…
…would manufacture custom-made devices using 3D printing – could be real competitors on the MD market in comparison with industrial firms that must comply with CE marking procedures. This risk…
…would manufacture custom-made devices using 3D printing – could be real competitors on the MD market in comparison with industrial firms that must comply with CE marking procedures. This risk…
…navigate the compliance pathway, link up with experts and deliver the maximum commercial benefits from the process. Audit Cycle The MDSAP implementation cycle is staged as follows, typically over three…
…navigate the compliance pathway, link up with experts and deliver the maximum commercial benefits from the process. Audit Cycle The MDSAP implementation cycle is staged as follows, typically over three…
…noting concerns and perceived compliance issues. Warning Letter Excerpt Introduction – “FDA has reviewed your firm’s current website (www.dynavisioninternational.com/) as noted in the below examples and determined that the Dynavision…
…noting concerns and perceived compliance issues. Warning Letter Excerpt Introduction – “FDA has reviewed your firm’s current website (www.dynavisioninternational.com/) as noted in the below examples and determined that the Dynavision…
…technique for non-invasive fat reduction, commonly marketed under the brand name “CoolSculpting.” CoolSculpting involves applying a specialized medical device that freezes and kills targeted fat areas in the body. In…
…technique for non-invasive fat reduction, commonly marketed under the brand name “CoolSculpting.” CoolSculpting involves applying a specialized medical device that freezes and kills targeted fat areas in the body. In…
