…body contact. For products with direct or indirect body contact, the device components are categorized following ISO 10993-1:2009 for nature of contact (e.g. surface, externally communicating, implant), type of tissue…
…body contact. For products with direct or indirect body contact, the device components are categorized following ISO 10993-1:2009 for nature of contact (e.g. surface, externally communicating, implant), type of tissue…
…(PS) and AAMI/CN20:2014 (PS) — establish requirements for connectors for enteral applications and common test methods. In a Federal Register notice dated February 11, the agency said the new standards…
…(PS) and AAMI/CN20:2014 (PS) — establish requirements for connectors for enteral applications and common test methods. In a Federal Register notice dated February 11, the agency said the new standards…
…Japan needed to file a very detailed QMS document. The old QMS requirements regarding audits for compliance were product-specific, meaning they were based on a comprehensive evaluation of the risks…
…Japan needed to file a very detailed QMS document. The old QMS requirements regarding audits for compliance were product-specific, meaning they were based on a comprehensive evaluation of the risks…
…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, December). FDA.gov Website. Retrieved January 31, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm429201.htm….
…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, December). FDA.gov Website. Retrieved January 31, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm429201.htm….
CFDA registration fees will not be insubstantial: Imported Class II device registrants will be charged about $34,000 for initial registration, while foreign Class III device registrants will have to pay…
CFDA registration fees will not be insubstantial: Imported Class II device registrants will be charged about $34,000 for initial registration, while foreign Class III device registrants will have to pay…
…serious complications for patients. This new material not only repelled bacteria but also attracted healthy cells. This combination was tested on cultures of healthy fibroblast cells and cultures of bacterial…
…serious complications for patients. This new material not only repelled bacteria but also attracted healthy cells. This combination was tested on cultures of healthy fibroblast cells and cultures of bacterial…
…management of chronic disease patients. Together, the companies aim to advance chronic care management using connected therapy to further improve therapy quality, increase convenience and drive patient engagement in managing…
…management of chronic disease patients. Together, the companies aim to advance chronic care management using connected therapy to further improve therapy quality, increase convenience and drive patient engagement in managing…
…head-to-head comparison against standard-of care (SOC) if available); other HTA body guidance published previously ( examples might include-Blue Cross and Blue Shield Association Technology Evaluation Center, Cochrane Collaboration, ECRI Institute,…
…head-to-head comparison against standard-of care (SOC) if available); other HTA body guidance published previously ( examples might include-Blue Cross and Blue Shield Association Technology Evaluation Center, Cochrane Collaboration, ECRI Institute,…
…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, December). FDA.gov Website. Retrieved January 31, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm429201.htm….
…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, December). FDA.gov Website. Retrieved January 31, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm429201.htm….
…more of the EU Directives on medical devices (i.e. 90/385/EEC, 93/42/EEC, 98/79/EC) are now subject to an additional unannounced audit. So how are manufacturers planning for this new type of…
…more of the EU Directives on medical devices (i.e. 90/385/EEC, 93/42/EEC, 98/79/EC) are now subject to an additional unannounced audit. So how are manufacturers planning for this new type of…
