AAMI Software and Health Information Technology

The Association for the Advancement of Medical Instrumentation (AAMI) is reorganizing its committee structure related to Software, Health IT, networks and related topics by forming a Software and Health Information Technology (SWIT) committee to oversee all related standards activities. The current plan is that this committee will coordinate all work in the Software, IT, MDDS, Interoperability, Mobile APPs, and Device Security committees to ensure consistency and avoid overlap. The first meeting of the SWIT will be held in December 2012 in conjunction with AAMI Standards Week in Daytona, FL.

Remote Webmeeting Assessments

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
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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