…for endoscopic devices in Asia, some companies are opening new training facilities, launching new greenfield operations, or investigating the possibility of acquisitions or joint ventures. In April 2015, Boston Scientific…
…for endoscopic devices in Asia, some companies are opening new training facilities, launching new greenfield operations, or investigating the possibility of acquisitions or joint ventures. In April 2015, Boston Scientific…
…a competent consultant to assist in the validation activities. The FDA, when reviewing software validations, will expect to see specific items that support claims of compliance with the Quality System…
…a competent consultant to assist in the validation activities. The FDA, when reviewing software validations, will expect to see specific items that support claims of compliance with the Quality System…
…document, “Postmarket Management of Cybersecurity in Medical Devices”, specifies how companies should proactively plan for and evaluate security gaps in consistency with the quality system regulation, along with encouraging information…
…document, “Postmarket Management of Cybersecurity in Medical Devices”, specifies how companies should proactively plan for and evaluate security gaps in consistency with the quality system regulation, along with encouraging information…
…of free options, such as ProjectLibre or Gantt Project. Our company commercialization process divides development into phases, where for example, Phase addresses early proof-of-concept and prototyping to de-risk technologies, understand…
…of free options, such as ProjectLibre or Gantt Project. Our company commercialization process divides development into phases, where for example, Phase addresses early proof-of-concept and prototyping to de-risk technologies, understand…
…technologies. During the opening keynote, IBM CEO Ginni Rometty and Medtronic CEO Omar Ishrak took the stage to announce a research concept for a cognitive app that uses predictive analytics…
…technologies. During the opening keynote, IBM CEO Ginni Rometty and Medtronic CEO Omar Ishrak took the stage to announce a research concept for a cognitive app that uses predictive analytics…
Regenerative medicine is most commonly defined as a process or application of a material, device or therapeutic that repairs, replaces or regenerates cells, tissues or organs. The value of the…
Regenerative medicine is most commonly defined as a process or application of a material, device or therapeutic that repairs, replaces or regenerates cells, tissues or organs. The value of the…
…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (December 22, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. ARB Medical, LLC. Accessed January 12, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm480523.htm…
…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (December 22, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. ARB Medical, LLC. Accessed January 12, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm480523.htm…
…China, demand for hospital furnishings and medical equipment will surge in the coming years. Medical device companies should look to provide clinic furnishings such as new therapeutic beds, exam tables,…
…China, demand for hospital furnishings and medical equipment will surge in the coming years. Medical device companies should look to provide clinic furnishings such as new therapeutic beds, exam tables,…
…don’t have the return on investment that big companies are looking for or the type of financial incentives for non-profit pediatric medical device developers in the academia, for example. We…
…don’t have the return on investment that big companies are looking for or the type of financial incentives for non-profit pediatric medical device developers in the academia, for example. We…
…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (November 19, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Accessed January 3, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm473657.htm…
…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (November 19, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Accessed January 3, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm473657.htm…
