FDA CDRH 510(k) External Infusion Pumps

“Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps”

This document was issued in draft form in August of 1994. Section II.G requires a hazard analysis and references the now obsolete reviewer guidance document for computer controlled medical devices, “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review,” the current FDA software submission guidance, “Guidance for theContent of Premarket Submissions for Software Contained in MEdical Devices,” should be used in place of the obolete document referenced.

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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