62304 Conformance Checklist Tool

This 62304 Conformance Checklist Tool is typically only available to Premium and higher subscribers, but is being made available to all on our website.  See our Subscribe page for information on subscriptions.

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.

We hope you find this 62304 Conformance Checklist Tool to be useful. If you have any questions leave a message below:

About the author

Brian Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®), a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.

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