March 2019 Standards Navigator Report

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Recent standards and regulatory activity overview
Medical device software

  • Following the failure of the DIS of 62304 to be approved, the IEC 62304 working group requested input from the ISO and IEC member countries. There was not a consensus on the approach to risk management for health software, but the working group discussed the replies and developed a new draft, which has . . .

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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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