FDA Quarterly MDR Reporting Pilot Program

FDA is initiating a pilot program that would allow quarterly reporting of MDRs for certain Class I and Class II devices in situation that do not reult in death or serious injury or a correction is not needed to prevent this. Companies can apply to participate in this pilot as indicated in the FDA announcement 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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