…new combinations of types of technology and the integration of electronics, smaller components, high frequency and wireless technology as well as monitoring, recording and control systems are market drivers for…
…new combinations of types of technology and the integration of electronics, smaller components, high frequency and wireless technology as well as monitoring, recording and control systems are market drivers for…
Beginning today, June 1, CDRH is accepting applications as part of an innovation challenge to encourage the development of medical devices and diagnostics that help fight the opioid crisis. Companies…
Beginning today, June 1, CDRH is accepting applications as part of an innovation challenge to encourage the development of medical devices and diagnostics that help fight the opioid crisis. Companies…
…https://medtechintelligence.com/feature_article/new-mdr-opportunity-knocks/ 3. IQ, OQ and PQ: The Backbone of Your Quality System https://medtechintelligence.com/feature_article/iq-oq-pq-backbone-quality-system/ 2. Becton Dickinson Receives FDA Warning Letter for Significant Violations https://medtechintelligence.com/news_article/becton-dickinson-receives-fda-warning-letter-significant-violations/ 1. New EU MDR Regulations and…
…https://medtechintelligence.com/feature_article/new-mdr-opportunity-knocks/ 3. IQ, OQ and PQ: The Backbone of Your Quality System https://medtechintelligence.com/feature_article/iq-oq-pq-backbone-quality-system/ 2. Becton Dickinson Receives FDA Warning Letter for Significant Violations https://medtechintelligence.com/news_article/becton-dickinson-receives-fda-warning-letter-significant-violations/ 1. New EU MDR Regulations and…
…leaves the component manufacturer in the dark. Component manufacturers understand the sensitivity around this topic, as OEMs see this information as proprietary. Yet, sharing more information with the component manufacturer…
…leaves the component manufacturer in the dark. Component manufacturers understand the sensitivity around this topic, as OEMs see this information as proprietary. Yet, sharing more information with the component manufacturer…
…gdprrequests@foodsafetytech.com gdprrequests@medtechintelligence.com gdprrequests@foodsafetytech.com. Disclaimer of liability: This website is compiled and maintained with the utmost care. Nevertheless, we cannot guarantee the accuracy, completeness and freedom of errors of the data…
…gdprrequests@foodsafetytech.com gdprrequests@medtechintelligence.com gdprrequests@foodsafetytech.com. Disclaimer of liability: This website is compiled and maintained with the utmost care. Nevertheless, we cannot guarantee the accuracy, completeness and freedom of errors of the data…
…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (April 2018). Inspections, Compliance, Enforcement, and…
…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (April 2018). Inspections, Compliance, Enforcement, and…
…region, most governments have at last instituted consistent hepatitis immunization programs. In addition, Asian nations have made significant progress in combating another traditional cause of liver cancer: Aflatoxins. Produced by…
…region, most governments have at last instituted consistent hepatitis immunization programs. In addition, Asian nations have made significant progress in combating another traditional cause of liver cancer: Aflatoxins. Produced by…
…An MDR is often a complaint, although doesn’t have to be. You need to have a complaint-handling process to deal with all that come in; however, keep in mind that…
…An MDR is often a complaint, although doesn’t have to be. You need to have a complaint-handling process to deal with all that come in; however, keep in mind that…
…bloodstream—and this issue and/or the attempt to remove the device could lead to complications that include bleeding, further blockage of blood vessels, more severe stroke symptoms or death. In the…
…bloodstream—and this issue and/or the attempt to remove the device could lead to complications that include bleeding, further blockage of blood vessels, more severe stroke symptoms or death. In the…
…numbers. https://www.securityfocus.com/news/11455 HIPAA Journal. Stolen Electromygraphy Device Contained 836 Patents PHI, says SSM Health. https://www.hipaajournal.com/stolen-electromyography-device-contained-836-patients-phi-says-ssm-health-8822/ Wikipedia. IEC 62304. https://en.wikipedia.org/wiki/IEC_62304 UL. FDA Recognizes UL 2900-1 Cybersecurity Standard for Medical Devices. https://www.ul.com/inside-ul/fda-recognizes-ul-2900-1-cybersecurity-standard-for-medical-devices/…
…numbers. https://www.securityfocus.com/news/11455 HIPAA Journal. Stolen Electromygraphy Device Contained 836 Patents PHI, says SSM Health. https://www.hipaajournal.com/stolen-electromyography-device-contained-836-patients-phi-says-ssm-health-8822/ Wikipedia. IEC 62304. https://en.wikipedia.org/wiki/IEC_62304 UL. FDA Recognizes UL 2900-1 Cybersecurity Standard for Medical Devices. https://www.ul.com/inside-ul/fda-recognizes-ul-2900-1-cybersecurity-standard-for-medical-devices/…
