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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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