…regulatory gods in Japan, similar to FDA and the Competent Authorities in Europe, have promised an increased oversight of device manufacturers in the coming year. There are just way too…
…regulatory gods in Japan, similar to FDA and the Competent Authorities in Europe, have promised an increased oversight of device manufacturers in the coming year. There are just way too…
…is due to a complaint, make sure a thorough complaint investigation is held, including the need to report potential adverse events. At the end of the day, device manufacturers must…
…is due to a complaint, make sure a thorough complaint investigation is held, including the need to report potential adverse events. At the end of the day, device manufacturers must…
…developing a software-intensive product, the TSP provides a framework that combines their personal process discipline skills with proven process management techniques. This enables them to produce high-quality software as a…
…developing a software-intensive product, the TSP provides a framework that combines their personal process discipline skills with proven process management techniques. This enables them to produce high-quality software as a…
…regulation. Washington, D.C.: U. S. Government Printing Office. Device master file. (2012). Emergo Group Website. Retrieved November 29, 2012, from http://www.emergogroup.com/services/japan/device-master-file-japan EN ISO 13485:2012. (2012, February). Medical devices – quality…
…regulation. Washington, D.C.: U. S. Government Printing Office. Device master file. (2012). Emergo Group Website. Retrieved November 29, 2012, from http://www.emergogroup.com/services/japan/device-master-file-japan EN ISO 13485:2012. (2012, February). Medical devices – quality…
…complete return in one sudden burst.” As Dr. D likes to say; “Even a blind squirrel finds a nut sometimes.” If this comment is coming from MHLW, device manufacturers should…
…complete return in one sudden burst.” As Dr. D likes to say; “Even a blind squirrel finds a nut sometimes.” If this comment is coming from MHLW, device manufacturers should…
…Selecting a Mobile App: Evaluating the Usability of Medical Applications, mHIMSS App Usability Work Group, July 2012. Fact Sheet – mHealth Task Force Recommendations, Federal Communications Commission, September 24, 2012….
…Selecting a Mobile App: Evaluating the Usability of Medical Applications, mHIMSS App Usability Work Group, July 2012. Fact Sheet – mHealth Task Force Recommendations, Federal Communications Commission, September 24, 2012….
…http://www.linguanaut.com/english_japanese.htm Ministerial Ordinance 169. (2004). MHLW ministerial ordinance 169 on standards for manufacturing control and quality control for medical devices and in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf…
…http://www.linguanaut.com/english_japanese.htm Ministerial Ordinance 169. (2004). MHLW ministerial ordinance 169 on standards for manufacturing control and quality control for medical devices and in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf…
…http://www.asknature.org/strategy/1bc69752671838d19b28981d5b5483f6 Chan, C.-J. L.-H. (2007). Comprehensive Organic Reactions in Aqueous Media, Second Edition. Hoboken NJ: Wiley-Interscience. Cone, Inc. (2008). Past. resent. Future. The 25th Anniversary of Cause Marketing:. Retrieved from…
…http://www.asknature.org/strategy/1bc69752671838d19b28981d5b5483f6 Chan, C.-J. L.-H. (2007). Comprehensive Organic Reactions in Aqueous Media, Second Edition. Hoboken NJ: Wiley-Interscience. Cone, Inc. (2008). Past. resent. Future. The 25th Anniversary of Cause Marketing:. Retrieved from…
…DG is all about understanding the components of corrective action and how to ensure an organization’s approach to corrective action is in compliance with Article 63 of MO 169. Enjoy!…
…DG is all about understanding the components of corrective action and how to ensure an organization’s approach to corrective action is in compliance with Article 63 of MO 169. Enjoy!…
…CAPA system with complaints; however, it is a daunting task attempting to defend why complaints did not result in CAPAs); and Collection and maintenance of impeccable complaint investigation records. What…
…CAPA system with complaints; however, it is a daunting task attempting to defend why complaints did not result in CAPAs); and Collection and maintenance of impeccable complaint investigation records. What…
