Day

December 24, 2018
24
Dec

The Essence of Design Input

December 24, 2018
Clearly one of the great struggles with medical device product design is to understand and finely tune the design input for our devices.  It is difficult but the payoff can be great when done well – pays off with development efficiency, greater certainty with safety risk control, and ultimately in customer satisfaction. In our training...
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24
Dec

Quick link to US FDA 21CFR820

December 24, 2018
It is always good to remind ourselves of exactly what the regulation says – often our corporate procedures can become “bloated” and lead some to believe that some specific activities and/or types of deliverables are required by the regulations.
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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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