…Is an anesthesia machine leaking? A BMET can troubleshoot that. Did a new dental chair come with installation instructions in German? A BMET can find the manual in other languages,…
…Is an anesthesia machine leaking? A BMET can troubleshoot that. Did a new dental chair come with installation instructions in German? A BMET can find the manual in other languages,…
…revolution traces its origins to U.S. technology companies, Asian manufacturers are getting in on the game with some novel devices. Take Tokyo-and California-based venture, Triple W, for example. The company…
…revolution traces its origins to U.S. technology companies, Asian manufacturers are getting in on the game with some novel devices. Take Tokyo-and California-based venture, Triple W, for example. The company…
Often, healthcare companies view regulations as cumbersome business challenges. The complexities can distract attention from why compliance matters. Recent events in the news, contaminated devices and counterfeit components, have reminded…
Often, healthcare companies view regulations as cumbersome business challenges. The complexities can distract attention from why compliance matters. Recent events in the news, contaminated devices and counterfeit components, have reminded…
…adults in the United States will have diabetes by 2050. Diabetes complications include heart attack, kidney failure, vision loss, limb amputation. Figure courtesy of AdvaMed. 1 in 9 healthcare dollars…
…adults in the United States will have diabetes by 2050. Diabetes complications include heart attack, kidney failure, vision loss, limb amputation. Figure courtesy of AdvaMed. 1 in 9 healthcare dollars…
…completed], U.S. Food and Drug Administration (FDA) Investigator [FDA inspector name] concluded an inspection of [your company] facility located at [your company address] and issued Inspectional Observations on the form…
…completed], U.S. Food and Drug Administration (FDA) Investigator [FDA inspector name] concluded an inspection of [your company] facility located at [your company address] and issued Inspectional Observations on the form…
…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 27, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Ultroid Technologies, Inc. Accessed November 9, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm463616.htm…
…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 27, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Ultroid Technologies, Inc. Accessed November 9, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm463616.htm…
…deadly superbug outbreak. After examining incidents, testing devices, observing hospital practices, reviewing literature, and interviewing clinicians and other healthcare professionals and suppliers, the institute’s Health Devices Group puts together the…
…deadly superbug outbreak. After examining incidents, testing devices, observing hospital practices, reviewing literature, and interviewing clinicians and other healthcare professionals and suppliers, the institute’s Health Devices Group puts together the…
…of catheter that had a liquid component. The company’s new factory in India was only set up for export. In the United States, the catheter was classified and registered as…
…of catheter that had a liquid component. The company’s new factory in India was only set up for export. In the United States, the catheter was classified and registered as…
Proto Labs is the world’s fastest source for on-demand, low-volume manufacturing. We make quick-turn prototypes and production parts including device handles, housings, strain reliefs and other medical application components. Tony…
Proto Labs is the world’s fastest source for on-demand, low-volume manufacturing. We make quick-turn prototypes and production parts including device handles, housings, strain reliefs and other medical application components. Tony…
…guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (October 5, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations….
…guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (October 5, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations….
