FDA Standards Recogniton List Update April 2016

FDA updated their list of Recognized Standards April 4, 2016. The full list is at the link provided. There were several updates related to software standards as listed below. The new edition of IEC 62304 1.1 2015-06 replaces the prior edition. The new 2014-2015 edition of IEEE 11073-20601 Personal Health Data communication replaces the previous 2010 edition.

In additon, there was one new standard recognized related to tsoftware. IEEE 11073-10419:2015 for Personal Health device communication for insulin pumps.

SoftwareCPR experts including those involved in development of IEC 62304 and its first Amendment are available to provide guidance on its implementation as well as training.

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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