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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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