Day

April 11, 2015
Quality Electrodynamics, LLC..Product: cois used in conjunction with MRI scanners . Date: 4/10/2015 Failure to document validation activities, as required by 21 CFR 820.75(a). Specifically, The setting (temperature and line speed) used during the validation studies for the reflow oven, which is part of the SMT (Surface Mount Technology) line, to determine the optimum settings...
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SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

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  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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