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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
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