- Paves the way
- Inspires a vision
- Pushes the envelope
- Encourages others
- Enables others to act
Tuesday, November 29, 2011
Thursday, November 10, 2011
FDA's report "Understanding Barriers to Device Quality"
FDA's Center of Device and Radiological Health (CDRH) recently published a report addressing the perceived barrier in medical device regulatory bodies and medical device industry.
It is interesting to see that FDA is taking a much more proactive and collaborative approach in working with industry in "Identifying the barriers" in all areas of medical device market activities, benchmarking best Quality practices in/outside of industry, and improving the transparency of quality data to general public in order make quality a major purchase consideration for HCP and other medical devices customers.
FDA's review on how Industry executive's perceive inspection activities and how their countermeasures created undesired abrasion between the Agency and Industry, also makes a pretty good read.
You can review the following webcast in the following link ( MS Silverlight required)
http://fda.yorkcast.com/webcast/SilverlightPlayer/Default.aspx?peid=652eaa1108614c6bbc76daf1a9b9d7fb1d
For the FDA report, see the follwing link.
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM277323.pdf
It is interesting to see that FDA is taking a much more proactive and collaborative approach in working with industry in "Identifying the barriers" in all areas of medical device market activities, benchmarking best Quality practices in/outside of industry, and improving the transparency of quality data to general public in order make quality a major purchase consideration for HCP and other medical devices customers.
FDA's review on how Industry executive's perceive inspection activities and how their countermeasures created undesired abrasion between the Agency and Industry, also makes a pretty good read.
You can review the following webcast in the following link ( MS Silverlight required)
http://fda.yorkcast.com/webcast/SilverlightPlayer/Default.aspx?peid=652eaa1108614c6bbc76daf1a9b9d7fb1d
For the FDA report, see the follwing link.
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM277323.pdf
Sunday, July 10, 2011
Hi there colleagues!
Welcome to my blog!
This is an open forum to meet and discuss with other Chinese-American Quality professionals aspiring to raise Quality standards in China,America and everywhere else.
My name is Phillip. I am working as a quality engineer in medical device industry, located in Silicon Valley, California. I am a certified ISO9001,13485 QMS auditor and certified ASQ six sigma green belt.
歡迎您來到CQPA的部落格!
我名字叫Phillip, 現任職於某大光學集團醫療儀器,品質管理部工程師. ISO9001:2008, ISO13485:2003品質管理系統審核員, 和 ASQ 認證6西格瑪綠帶.
這是一個可以讓諸位留美,中國大陸, 海外的華裔品質管理人員/工程師, 及其他有意回國發展品質管理朋友討論QA/QC, ISO9001, 13485, 14001 和其他有關品質管理的網上論壇.
This is an open forum to meet and discuss with other Chinese-American Quality professionals aspiring to raise Quality standards in China,America and everywhere else.
My name is Phillip. I am working as a quality engineer in medical device industry, located in Silicon Valley, California. I am a certified ISO9001,13485 QMS auditor and certified ASQ six sigma green belt.
歡迎您來到CQPA的部落格!
我名字叫Phillip, 現任職於某大光學集團醫療儀器,品質管理部工程師. ISO9001:2008, ISO13485:2003品質管理系統審核員, 和 ASQ 認證6西格瑪綠帶.
這是一個可以讓諸位留美,中國大陸, 海外的華裔品質管理人員/工程師, 及其他有意回國發展品質管理朋友討論QA/QC, ISO9001, 13485, 14001 和其他有關品質管理的網上論壇.
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