HealthIT ONC Quality System Standard Presentation

HIT Implementation, Usability and Safety Workgroup meeting on Friday, February 6, 2015 – SoftwareCPR® Partners Sherman Eagles and Alan Kusinitz gave a presentation at ONC’s request with recommendations on an approach to HealthIT provider quality systems regulation and standards. In addition to providing background on quality systems, SoftwareCPR® recommended that a standard or guidance be written with representation from HealthIT vendors, users and regulators under the auspices of AAMI, and that it be written using IT/software terminology without direct inclusion of medical device software or quality system standard; but with flexibility to allow organizations that have implemented systems using these standard or other general software/IT quality standards or methodologies to continue their approach. A copy of the SoftwareCPR® slides can be viewed at the following link: SoftwareCPR-HealthIT-Feb6-2015 Presentation

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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