FDA CDRH 510(k) Immersion Hydrobaths

“Guidance Document for the Preperation of Premarket Notification [510(k)] Applications for Immersion Hydrobaths”

This document was issued July of 1995. It references the now obsolete 1991 FDA reviewer guidance “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review.” The current FDA software submission guidance, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” should be referred to in its place. This guidance document stresses the provision of requirements and design information, development process information, verification and validation information, test results and analysis, as well as the software hazard analysis. It also stresses that provision of minimal information may not be adequate to allow the reviewer to fully assess the software and stresses that pass/fail criteria and a system level functional test plan are important to the review as well as traceability of the safety concerns throughout development.

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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