March 20, 1997
Irwin Memorial Blood Centers 3/20/97 Blood Center Please be advised that the agency’s memorandum dated April 6, 1988, entitled “Recommendations for Implementation of Computerization in Blood Establishments” indicates as a data security issue that “if key elements of the database are changed, these changes should be traceable as to the time and person making the...
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Cordis Corporation 3/19/97 Stent Delivery 2. The validation of the balloon forming machines conducted from April 1995 to February 12, 1996 is inadequate due to the following: A. The Programmable Logic Controller which controls the balloon forming machine was not qualified.
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Updated Risk Management training course now available.  Includes:

  • Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

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