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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.