This week Medtronic announced it received both the CE Mark and FDA approval for its Avalus pericardial aortic surgical valve. The company touts it as the only stented surgical aortic…
This week Medtronic announced it received both the CE Mark and FDA approval for its Avalus pericardial aortic surgical valve. The company touts it as the only stented surgical aortic…
…for damage Cross-checking contents against the packing list Documenting computer-controlled instrumentation Verifying communication and connections with peripheral units Using IQ stickers to tag instruments Keeping a record of validation and…
…for damage Cross-checking contents against the packing list Documenting computer-controlled instrumentation Verifying communication and connections with peripheral units Using IQ stickers to tag instruments Keeping a record of validation and…
…others, who will talk about the most relevant issues in robotics that we are dealing with today, such as: The cost and value of robotics Complex robotic hysterectomy The urologic…
…others, who will talk about the most relevant issues in robotics that we are dealing with today, such as: The cost and value of robotics Complex robotic hysterectomy The urologic…
…MDR will bring about a number of changes that manufacturers need to be thinking about immediately, if they haven’t already begun. It’s critical that they reach full compliance within the…
…MDR will bring about a number of changes that manufacturers need to be thinking about immediately, if they haven’t already begun. It’s critical that they reach full compliance within the…
…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…
