AAMI TIR 80001-2-5 Distributed Alarm Systems

ANSI/AAMI/IEC TIR80001-2-5:2014 “Application of risk management for IT-networks incorporating medical devices Part 2-5: Application guidance: Guidance on distributed alarm systems” has been published. Sherman Eagles of SoftwareCPR was a co-chair for this.

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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:

  • 62304 compliance
  • Regulatory submission pre-review
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  • Overall ISO 14971 risk management
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