Day

July 27, 2018
27
Jul

FDA Examples of Cleared Apps

July 27, 2018
FDA provides examples of cleared Mobile Medical Apps.
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27
Jul

FDA Software Precertification News

July 27, 2018
Software-based medical devices tend to develop more quickly than typical hardware-based medical devices; so, in response, the FDA has turned to an agile regulatory model for software as a medical device (“SaMD”). The FDA describes the Software Precertification Program as a voluntary pathway, with tailored assessments of the safety and effectiveness of software technologies. Rather...
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27
Jul

FDA Clears Home Urinalysis Using Smartphones

July 27, 2018
Dip.io was cleared for clinical urinalysis. The device includes test strips and a color coded card that is readable by smartphone to provide a result for several conditions including infection.
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SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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