…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…
FDA has released information related to concerns over whether the Zoll Medical’s LifeVest 4000 device will fail to deliver treatment. According to a safety alert via MedWatch, if the LifeVest…
FDA has released information related to concerns over whether the Zoll Medical’s LifeVest 4000 device will fail to deliver treatment. According to a safety alert via MedWatch, if the LifeVest…
…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…
…program will ultimately allow us to implement a robust and enduring pathway across the entire agency to expedite access to such products as we fulfill our commitment to our Nation’s…
…program will ultimately allow us to implement a robust and enduring pathway across the entire agency to expedite access to such products as we fulfill our commitment to our Nation’s…
For the past several years, wearable biosensors have been all the rage. Consumers have been using them for everything from tracking their exercise regimens to monitoring blood pressure. But do…
For the past several years, wearable biosensors have been all the rage. Consumers have been using them for everything from tracking their exercise regimens to monitoring blood pressure. But do…
Last week FDA issued a warning letter to Becton Dickinson after finding several violations of law following an agency inspection of the company’s facility in New Jersey. The violations include…
Last week FDA issued a warning letter to Becton Dickinson after finding several violations of law following an agency inspection of the company’s facility in New Jersey. The violations include…
Edwards LifeSciences has announced a recall of its Certitude Delivery System, which is used to deliver the company’s SAPIEN 3 transcatheter heart valve. The issue is a molding overflow defect…
Edwards LifeSciences has announced a recall of its Certitude Delivery System, which is used to deliver the company’s SAPIEN 3 transcatheter heart valve. The issue is a molding overflow defect…
…hindrance to innovation, especially due to the fact that it hits the small companies the hardest. And these small companies may not benefit from the reform bill’s corporate tax cut…
…hindrance to innovation, especially due to the fact that it hits the small companies the hardest. And these small companies may not benefit from the reform bill’s corporate tax cut…
…that you market: (1) May have caused or contributed to a death or serious injury. Compliance for Dummies Customer complaints and the review of customer complaints to ensure they do…
…that you market: (1) May have caused or contributed to a death or serious injury. Compliance for Dummies Customer complaints and the review of customer complaints to ensure they do…
…– remove this computer tool from those which have only a purely administrative character (argument advanced by the French Government). He added: “From the patient’s collected data (which may come…
…– remove this computer tool from those which have only a purely administrative character (argument advanced by the French Government). He added: “From the patient’s collected data (which may come…
