FDA CDRH Human Factors Do It By Design

FDA CDRH’s “Do It By Design: An Introduction To Human Factors In Medical Devices ” December 1996. FDA has been increasingly concerned about human factors design a of medical devices to ensure safe and effective use of the devices by their intended users in their real environment. There many references to software design and user interfaces in this document as well as examples of human factor errors related to software. This document t also includes information and suggestions on how to design good user faces, pitfalls to avoid, and stresses the need for usability testing.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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