March 23, 2004
Company: Michigan Instruments Inc.Product: Thumper Model 1007 Mechanical CPR System Date: 3/23/04 You failed to perform or document the verification or validation of production process changes, such as the Inspiratory Time Test Specification, _____ on 12/17/2002 and the _____ software changes on 11/7/2000 (FDA-483 #11, c. and # 11, i) as required by 21 CFR...
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The AAMI Software Risk Management Technical Information Report draft comment period ended March 1, 2004. Comments were generally positive.The next step is a working group meeting May 11-12, 2004 to resolve comments and do a final edit to prepare the document for formal ballot. Contact one of the co-chairs if you are not a member...
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