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Q of the week

Q: Do clinical trials ever go wrong?

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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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US FDA Warning Letters in Clinical Investigation for the Month of December 2009   by GCP HelpDesk on 2009-12-31 09:10:00
 Regulatory/FDA Warning and Notice of Violation Letters to Pharmaceutical Companies
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US FDA Warning Letters in Clinical Investigation for the Month of December 2009
by GCP HelpDesk on 2009-12-31 09:10:00
0 4655 by GCP HelpDesk
on 2009-12-31 09:10:00
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