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July 28, 2020
Do you understand the Q-Sub Guidance? The FDA issued the guidance document Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program in 2019, but it has taken some time for the industry to understand all the facets of the program. The guidance covers a wide range of FDA submissions – IDE/PMA/HDE applications, de novo...
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On July 16, 2020, FDA issued 510(k) Approval for AI Imaging Analytics Device HealthMammo, a device manufactured by Zebra Medical Vision Ltd. As reported in the New York Times, HealthMammo is an artificial intelligence (AI) product that analyzes mammograms for suspicious lesions. Radiologists can use the HealthMammo results to prioritize which mammogram images need attention...
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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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