…“I am sorry.” For device manufactures failing to comply with Ministerial Ordinance 169, these will be the first three words received from PMDA, followed by “your company’s medical devices are…
…“I am sorry.” For device manufactures failing to comply with Ministerial Ordinance 169, these will be the first three words received from PMDA, followed by “your company’s medical devices are…
…continue to be the Achilles heel for many medical device companies. The problem is rooted in effective supplier management. You see, there is simple seven-letter word “control” that is often…
…continue to be the Achilles heel for many medical device companies. The problem is rooted in effective supplier management. You see, there is simple seven-letter word “control” that is often…
…http://www.emergogroup.com/services/japan/medical-device-approval-japan 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.emergogroup.com/services/japan/medical-device-approval-japan 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…
…all applicable regulatory and statutory requirements (remember there is no such thing as minimum compliance, or maximum compliance, there is just compliance); and Identify necessary requirements, deemed applicable by the…
…all applicable regulatory and statutory requirements (remember there is no such thing as minimum compliance, or maximum compliance, there is just compliance); and Identify necessary requirements, deemed applicable by the…
…and I am very glad that they did because it can become a platform to revolutionize the medical device community! Fig. 1: Carrot Wasp (Gasteruptiidae sp.) Courtesy Inmagine.com There are…
…and I am very glad that they did because it can become a platform to revolutionize the medical device community! Fig. 1: Carrot Wasp (Gasteruptiidae sp.) Courtesy Inmagine.com There are…
The key for successfully complying with MO 169 is not rooted in comprehending the similarities of the Japanese regulation to ISO 13485:2003, but in understanding, embracing, and complying with the…
The key for successfully complying with MO 169 is not rooted in comprehending the similarities of the Japanese regulation to ISO 13485:2003, but in understanding, embracing, and complying with the…
…you have already reached the conclusion that the doctor believes that there is no such thing as minimum compliance or maximum compliance, just compliance. If the readers have a firm…
…you have already reached the conclusion that the doctor believes that there is no such thing as minimum compliance or maximum compliance, just compliance. If the readers have a firm…
…2012, from http://www.emergogroup.com/services/japan Gross, A. (2010, June). Presentation: Pacific Bridge Medical: China and Japan quality management systems. Retrieved July 8, 2012, from http://www.fdanews.com/ext/files/Conference/ Ministerial Ordinance 169. (2004). MHLW ministerial ordinance…
…2012, from http://www.emergogroup.com/services/japan Gross, A. (2010, June). Presentation: Pacific Bridge Medical: China and Japan quality management systems. Retrieved July 8, 2012, from http://www.fdanews.com/ext/files/Conference/ Ministerial Ordinance 169. (2004). MHLW ministerial ordinance…
…& Hwang, T. (1995, January). Changing regulatory environment in Japan’s medical device industry opens new opportunities for American companies. Retrieved June 29, 2012, from http://www.pacificbridgemedical.com. Marketing Authorization Holder for Japan….
…& Hwang, T. (1995, January). Changing regulatory environment in Japan’s medical device industry opens new opportunities for American companies. Retrieved June 29, 2012, from http://www.pacificbridgemedical.com. Marketing Authorization Holder for Japan….
…http://www.emergogroup.com/services/japan 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.emergogroup.com/services/japan 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…
