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FDA 510(k) process Meeting of 2/18/10
FDA staff say agency may need new device powers Reuters on 2/18/10 wrote about the well attended meeting by industry representatives.
FDA Unveils Initiative to Reduce Radiation Exposure
FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging FDA News Release on Feb 9, 2010 on subject.
Medical Device Sector Could Face Tougher Regulatory Pathway
FDA Could Get Tougher on 510(k) and Other Regulatory Pathways The Wall Street Journal on FDA re-evaluation of their approval processes.
Eisner Safety Consultants Newsletter #4 Available
Eisner Safety Consultants Newsletter #4 Available on the web This issue we are going to focus on primarily on the MDD Amendment 2007/47/EC as the deadline to comply is very soon. You must comply with the MDD Amendment 2007/47/EC as