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62304 can provide an excellent framework from which to design a software process for medical device, medical mobile app, and/or HealthIT software. 62304 was created specifically for this type of software – it was not just borrowed from another industry. It is a recognized FDA consensus standard and establishes much of what is expected for SDLC activities and documentation.
Keep in mind that 62304 does not cover all aspects of 21 CFR 820.30 however. It should be used in conjunction with system/device level safety standards. Also, while 62304 allows for omission of activities and deliverables in an SDLC, FDA expectations may differ based on many factors.
Download our 62304 Conformance Checklist Tool here: 62304SoftwareCPR-Checklist
SoftwareCPR can provide conformance assessments, training, or expert consultation for efficient use and implementation of 62304 for medical device software as well as for unregulated health software. SoftwareCPR experts, including those involved in development of IEC 62304 and related standards, are available to provide guidance on its implementation as well as training.
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