…Scientific, Covidien, and Insulet Corp. tied with two recalls each. One of the most serious recalls in 2015 involved HeartWare’s Heart Ventricular Assist Device (HVAD). The company initiated five recalls…
…Scientific, Covidien, and Insulet Corp. tied with two recalls each. One of the most serious recalls in 2015 involved HeartWare’s Heart Ventricular Assist Device (HVAD). The company initiated five recalls…
…thing as maximum compliance or minimum compliance, there is only compliance.” It is Dr. D’s favorite quote. Enjoy! Warning Letter – December 11, 2015 For this last guidance of 2015,…
…thing as maximum compliance or minimum compliance, there is only compliance.” It is Dr. D’s favorite quote. Enjoy! Warning Letter – December 11, 2015 For this last guidance of 2015,…
…has evolved. 4: The Integration of Complaint Handling and Risk Management A review of the important aspects of risk management and post-market surveillance processes, and how to resolve common concerns….
…has evolved. 4: The Integration of Complaint Handling and Risk Management A review of the important aspects of risk management and post-market surveillance processes, and how to resolve common concerns….
With Christmas rapidly approaching, Dr. D hopes all of the readers that celebrate Christmas have completed their shopping. FYI, Dr. D has not but will begin shopping with a vengeance…
With Christmas rapidly approaching, Dr. D hopes all of the readers that celebrate Christmas have completed their shopping. FYI, Dr. D has not but will begin shopping with a vengeance…
…high-energy shock to set the heart back to a normal rhythm. The vest is worn outside of the body. “Today’s pediatric approval was based on published studies and a company…
…high-energy shock to set the heart back to a normal rhythm. The vest is worn outside of the body. “Today’s pediatric approval was based on published studies and a company…
…Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (November 2, 2015). Inspections, Compliance, Enforcement, and Criminal…
…Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (November 2, 2015). Inspections, Compliance, Enforcement, and Criminal…
…Nigel Davis, CEO of Medherant in a company release. “Thus our patches provide a better experience for patients, enhance safety and deliver increased efficacy, which will lead to economic benefits…
…Nigel Davis, CEO of Medherant in a company release. “Thus our patches provide a better experience for patients, enhance safety and deliver increased efficacy, which will lead to economic benefits…
…Since the new regulations on CER have come out, many Western device companies have asked me how they can do CERs as a way to avoid local clinical studies. While…
…Since the new regulations on CER have come out, many Western device companies have asked me how they can do CERs as a way to avoid local clinical studies. While…
…with the medical and dental sector comprising 15% of the entire market. The industry as a whole experienced a 22.6% compound annual growth rate from 2010–2015 and is anticipated to…
…with the medical and dental sector comprising 15% of the entire market. The industry as a whole experienced a 22.6% compound annual growth rate from 2010–2015 and is anticipated to…
…in making decisions about their health. The desire for more control and convenience is driving the adoption of certain medical devices, but the issue becomes more complex when considering the…
…in making decisions about their health. The desire for more control and convenience is driving the adoption of certain medical devices, but the issue becomes more complex when considering the…
