FDA Electronic Labeling Usage for BECS.

FDA CBER indicated to SoftwareCPR in informal question and answer that it allows blood establishment computer software (BECS) firms to provide their customers electronic labeling for such devices. However, if the customer requests a hardcopy it must be provided. Therefore, in pre-market submissions if electronic labeling is being used then both electronic and the hard copy labeling must be submitted.

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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