Julie:
We do lots of these for device clients.
Once you have the chemical portion of the L & E assessment (what comes out of a device upon appropriate extractions and how much of each such moiety per device), the risk assessment part typically takes us a week calendar time (performed in parallel with other ongoing tasks).
Give me a call is you want - local - 919-233-2926. I will be in the office today, though staff has day off for Good Friday.
Best Regards
Shayne
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Shayne Cox Gad PhD, DABT,
ATS
Principal
Gad Consulting Services
Cary NC
United States
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Original Message:
Sent: 04-17-2014 12:09
From: Julie Omohundro
Subject: Risk-Based Biocompatiblity Assessment Timeframes?
If you have experience with ISO 10993 risk-based biocompatiblity assessment with new devices, I would like to know about how long it takes to get from the date on which you devices available for testing to the date you have completed the risk assessment that is based on the results of chemical characterization and quantification of degradation products.
Thanks,
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Julie Omohundro RAC
Durham NC
United States
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