FDA UDI Final Rule

FDA published its Final Universal Device Identification Rule This includes that standalone software need only provide a means to display a human readable UDI. The full link to FDA’s web page on the UDI rule is at the link provided.

Upcoming Training

Agile Methods for Medical Device and Health IT Software

One day course that expands on the software risk management topics covered in our IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software course. Essentially the same topics are covered but in greater depth with more attention to hands-on analysis of examples.

Email training@softwarecpr.com for more info.

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