…innovation”, the new European Medical Device Regulation (MDR) was finally published in the Official Journal of the European Union on May 5, 2017. This new regulation replaces both the previous…
…innovation”, the new European Medical Device Regulation (MDR) was finally published in the Official Journal of the European Union on May 5, 2017. This new regulation replaces both the previous…
…it is developed under a compulsory license. China’s National Health and Family Planning Commission plans to issue more detailed information on the compulsory license process and more clearly define what…
…it is developed under a compulsory license. China’s National Health and Family Planning Commission plans to issue more detailed information on the compulsory license process and more clearly define what…
…Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (July 2017). Inspections, Compliance, Enforcement, and Criminal Investigations….
…Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (July 2017). Inspections, Compliance, Enforcement, and Criminal Investigations….
…capable of producing all of the required components. The manufacturers were all expecting to procure or source components from other companies in order to fulfill the requirements. Of course, this…
…capable of producing all of the required components. The manufacturers were all expecting to procure or source components from other companies in order to fulfill the requirements. Of course, this…
…of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (May 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Oxford Performance Materials. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm557872.htm….
…of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (May 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Oxford Performance Materials. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm557872.htm….
…We hear it over and over again from component manufacturers that OEMs come to them too late, when they’ve already made the decision on the type of component and the…
…We hear it over and over again from component manufacturers that OEMs come to them too late, when they’ve already made the decision on the type of component and the…
…and benefits.” – Scott Gottlieb, M.D., FDA commissioner In a blog on FDA Voice, Gottlieb emphasizes the cost component of developing technology and patient ability to access them. The 21st…
…and benefits.” – Scott Gottlieb, M.D., FDA commissioner In a blog on FDA Voice, Gottlieb emphasizes the cost component of developing technology and patient ability to access them. The 21st…
…musculoskeletal healthcare. Through a combination of organic growth and strategic acquisitions, Zimmer Biomet’s revenue has doubled and the Company has established a leading portfolio of technologies, solutions and personalized services.”…
…musculoskeletal healthcare. Through a combination of organic growth and strategic acquisitions, Zimmer Biomet’s revenue has doubled and the Company has established a leading portfolio of technologies, solutions and personalized services.”…
…added that the long-term goal of the CARDIS team is to make the scanner available to general practitioners for use in routine health exams. De Melis anticipates the scanner will…
…added that the long-term goal of the CARDIS team is to make the scanner available to general practitioners for use in routine health exams. De Melis anticipates the scanner will…
INSPIRIS valve with inside view of VFit technology. Image courtesy of Edwards Lifesciences. Last week FDA approved Edwards Lifesciences Corp.’s Inspiris Resilia aortic valve, which the company is calling a…
INSPIRIS valve with inside view of VFit technology. Image courtesy of Edwards Lifesciences. Last week FDA approved Edwards Lifesciences Corp.’s Inspiris Resilia aortic valve, which the company is calling a…
