First AAMI Agile Software Compliance Course

Last week was the first offering of AAMI’s course on Agile Software Methods Compliance. Approximately 30 students attended from a wide range of medical device manufacturers including software engineers, quality, compliance, and regulatory managers. As a first offering this level of enrollment shows the high interest in more efficient and effective approaches to medical device software.
Brian Pate and Alan Kusinitz of SoftwareCPR as well as Kelly Weyrauch of Medtronic served as instructors. AAMI is currently scheduling the second offering in the first half of 2014. For more information leave a message on our site or email SoftwareCPR can also provide on-site consulting and training to assist you in efficient and compliant Agile implementations tailored to your quality system, culture, device type, and preferences.

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

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