February 2, 2012 - SoftwareCPR

Feb

EU Guidance Classification of Standalone Software

February 2, 2012Sherman EaglesNews

The European Commission has issued a final guidance on standalone software entitled: “GUIDELINES ON THE QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE USED IN HEALTHCARE WITHIN THE REGULATORY FRAMEWORK OF MEDICAL DEVICES.” Updated in 2015.

Feb

Manufacturer remote access to medical device

February 2, 2012Alan KusinitzNews

For devices where the medical device manufacturer intends to maintain remote access capability for service and updates, controls are needed to ensure this access does not compromise the security or operation of the device. There is one FDA recognized standard that addresses this for clinical laboratory devices, but many of the provisions could be instructive...

Feb

IOM Report on Health IT and patient Safety

February 2, 2012Alan KusinitzNews

The Institute of Medicine report is at the link provided. Health IT and Patient Safety Report

EU Guidance Classification of Standalone Software

Manufacturer remote access to medical device

IOM Report on Health IT and patient Safety

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Corporate Office

Day

EU Guidance Classification of Standalone Software

Manufacturer remote access to medical device

IOM Report on Health IT and patient Safety

Upcoming Training

Subscription Services

Corporate Office