…the second largest single country medical device market in the world,” says Gross. “Also, Japan has a very developed medical community, so Western companies with new technologies will normally find…
…the second largest single country medical device market in the world,” says Gross. “Also, Japan has a very developed medical community, so Western companies with new technologies will normally find…
Medical device reprocessing is a common practice in hospitals and other healthcare facilities. The practice can save costs and prevent more waste from entering landfills. However, when devices are not…
Medical device reprocessing is a common practice in hospitals and other healthcare facilities. The practice can save costs and prevent more waste from entering landfills. However, when devices are not…
…could only complete a small number of tests. In fact, “the company conducted the vast majority of patient tests on modified and industry-standard commercial analyzers manufactured by others,” according to…
…could only complete a small number of tests. In fact, “the company conducted the vast majority of patient tests on modified and industry-standard commercial analyzers manufactured by others,” according to…
…who do not invest early in their compliance preparations. Conversely, IVDR compliance pioneers will be perfectly situated to meet market demands that late movers will be denied access to until…
…who do not invest early in their compliance preparations. Conversely, IVDR compliance pioneers will be perfectly situated to meet market demands that late movers will be denied access to until…
…820 Compliance. Charleston, SC: Amazon. FDA. (March 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Hoya Corp. – Pentax Life Division. Accessed March 11, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm600342.htm. FDA. (March 2018)….
…820 Compliance. Charleston, SC: Amazon. FDA. (March 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Hoya Corp. – Pentax Life Division. Accessed March 11, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm600342.htm. FDA. (March 2018)….
…expects 50% of the testing for the human factors study to be completed by Olympus and Pentax by May 31 and 100% by June 30. “If the companies fail to…
…expects 50% of the testing for the human factors study to be completed by Olympus and Pentax by May 31 and 100% by June 30. “If the companies fail to…
…agencies like the FDA, NHS and EU Commission. There are a number of regulatory considerations and industry best practices that manufacturers and distributors of medical devices need to know as…
…agencies like the FDA, NHS and EU Commission. There are a number of regulatory considerations and industry best practices that manufacturers and distributors of medical devices need to know as…
…whether these companies were qualified. The impetus for choosing this Japanese trading company was the fact that this trading company was going to invest $5 million in the client’s company,…
…whether these companies were qualified. The impetus for choosing this Japanese trading company was the fact that this trading company was going to invest $5 million in the client’s company,…
Today FDA announced that it has expanded approval of Abbott’s Masters Series Mechanical Heart Valve to include a size small enough to treat newborns. The 15-mm Hemodynamic Plus valve provides…
Today FDA announced that it has expanded approval of Abbott’s Masters Series Mechanical Heart Valve to include a size small enough to treat newborns. The 15-mm Hemodynamic Plus valve provides…
…2018: Healthcare and Life Sciences. In North Highland. Retrieved from http://www.northhighland.com/insights/thought-leadership/north-highland-beacon-healthcare Shah, S. (2017, August 31). FDA recalls close to half-a-million pacemakers over hacking fears. In Engadget. Retrieved from https://www.engadget.com/2017/08/31/fda-pacemakers-abbott-hacking/…
…2018: Healthcare and Life Sciences. In North Highland. Retrieved from http://www.northhighland.com/insights/thought-leadership/north-highland-beacon-healthcare Shah, S. (2017, August 31). FDA recalls close to half-a-million pacemakers over hacking fears. In Engadget. Retrieved from https://www.engadget.com/2017/08/31/fda-pacemakers-abbott-hacking/…
