…is achieved This opens up commercial opportunities for MDR compliance pioneers, who will be able to serve the resulting market segments while their competitors remain excluded Our research combined a…
…is achieved This opens up commercial opportunities for MDR compliance pioneers, who will be able to serve the resulting market segments while their competitors remain excluded Our research combined a…
…patients. Thus, oftentimes there is an under-utilization of new ophthalmic lenses and products at top hospitals. The majority of doctors show no intention of purchasing new lenses, and they normally…
…patients. Thus, oftentimes there is an under-utilization of new ophthalmic lenses and products at top hospitals. The majority of doctors show no intention of purchasing new lenses, and they normally…
…the compliance lapse occurred (a.k.a. root cause). If the compliance issue impacts product already entered into commerce, the FDA is going to want to understand the potential impact (risk) to…
…the compliance lapse occurred (a.k.a. root cause). If the compliance issue impacts product already entered into commerce, the FDA is going to want to understand the potential impact (risk) to…
Today FDA sent out an alert about Vyaire Medical recalling its AirLife Humidification Chamber and Heated Breathing Circuit Kits. The Class I recall is a result of a manufacturing error…
Today FDA sent out an alert about Vyaire Medical recalling its AirLife Humidification Chamber and Heated Breathing Circuit Kits. The Class I recall is a result of a manufacturing error…
…working in the smartphone market pre-Apple iPhone. At that time, the market was dominated by companies like Nokia, Palm and Research in Motion’s Blackberry. These companies hired the best human…
…working in the smartphone market pre-Apple iPhone. At that time, the market was dominated by companies like Nokia, Palm and Research in Motion’s Blackberry. These companies hired the best human…
…Identification of Notified Body for certification under New EU MDR Certification of new devices under New EU MDR Re-certification of existing devices and re-classified devices under New EU MDR Regulatory…
…Identification of Notified Body for certification under New EU MDR Certification of new devices under New EU MDR Re-certification of existing devices and re-classified devices under New EU MDR Regulatory…
…world,” said Joe Panetta, president and CEO of California life sciences industry association Biocom. “Nevertheless, Biocom continues to support permanent repeal of the tax and looks forward to working with…
…world,” said Joe Panetta, president and CEO of California life sciences industry association Biocom. “Nevertheless, Biocom continues to support permanent repeal of the tax and looks forward to working with…
…the chronic disease and intervene early to prevent further complications. The disease management industry in the United States is comprised of very large companies such as Eli Lilly, Merck-Medco Managed…
…the chronic disease and intervene early to prevent further complications. The disease management industry in the United States is comprised of very large companies such as Eli Lilly, Merck-Medco Managed…
…message, it does not specify that the device cannot be used and that Zoll should be immediately contacted. As of January 17, FDA was made aware of one patient death…
…message, it does not specify that the device cannot be used and that Zoll should be immediately contacted. As of January 17, FDA was made aware of one patient death…
…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (November 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. GPC Medical Ltd. Accessed January 15, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm589686.htm…
…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (November 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. GPC Medical Ltd. Accessed January 15, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm589686.htm…
