…is infusion errors and new editions include hazards involving surgical staplers and software. Last year’s list specifically called out poor cleaning of flexible endoscopes, whereas this year ECRI cast a…
…is infusion errors and new editions include hazards involving surgical staplers and software. Last year’s list specifically called out poor cleaning of flexible endoscopes, whereas this year ECRI cast a…
…component will function reliably and safely over many years (e.g., for one million cycles). It’s something else to prevent use errors—another type of failure—and make sure that people will not…
…component will function reliably and safely over many years (e.g., for one million cycles). It’s something else to prevent use errors—another type of failure—and make sure that people will not…
…its policy and clarifies the agency’s interpretations of the regulatory requirements under 21 CFR part 803. – FDA release FDA has also scheduled a webinar to help companies understand the…
…its policy and clarifies the agency’s interpretations of the regulatory requirements under 21 CFR part 803. – FDA release FDA has also scheduled a webinar to help companies understand the…
…requirements. In some cases, a recall involves a particular defective component. Are you aware of the regulations surrounding the component? Harvey uses the example of a defective lithium ion battery,…
…requirements. In some cases, a recall involves a particular defective component. Are you aware of the regulations surrounding the component? Harvey uses the example of a defective lithium ion battery,…
…combination product’s business risk compare to normal project’s business risk (return on investments, net present values, etc.). Ensure the senior management has visibility to the market potential, competitive landscape, regulatory…
…combination product’s business risk compare to normal project’s business risk (return on investments, net present values, etc.). Ensure the senior management has visibility to the market potential, competitive landscape, regulatory…
…– 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Spiegelberg Gmbh & Co. KG. Accessed October 31, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515340.htm…
…– 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Spiegelberg Gmbh & Co. KG. Accessed October 31, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515340.htm…
…to the doctor’s office. Here’s the question: Will these new technologies completely eliminate personal contact with physicians? What technical requirements must met and what is the security level of the…
…to the doctor’s office. Here’s the question: Will these new technologies completely eliminate personal contact with physicians? What technical requirements must met and what is the security level of the…
…Clinton’s campaign has not commented on one of the biggest issues brought on by the ACA that is affecting medical device companies: The 2.5% medical device excise tax, which was…
…Clinton’s campaign has not commented on one of the biggest issues brought on by the ACA that is affecting medical device companies: The 2.5% medical device excise tax, which was…
…11% increase compared to the prior year period. According to a company release, Boston Scientific reported the following growth: Business Units MedSurg: 15% Cardiovascular: 13% Rhythm Management: 4% Geographies United…
…11% increase compared to the prior year period. According to a company release, Boston Scientific reported the following growth: Business Units MedSurg: 15% Cardiovascular: 13% Rhythm Management: 4% Geographies United…
Today Medtronic announced FDA approval of its CoreValve Evolut, the largest transcatheter aortic valve replacement (TAVR) available in the United States. The R 34-mm valve is indicated to treat severe…
Today Medtronic announced FDA approval of its CoreValve Evolut, the largest transcatheter aortic valve replacement (TAVR) available in the United States. The R 34-mm valve is indicated to treat severe…
