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Tuesday, 19 October 2021 8:30 AM - Thursday, 21 October 2021 4:30 PM EDT
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Valid for one person to join via Zoom on Oct 19-21, 2021, 8:30 am to 4:30 pm EDT. Students required to use camera at many points during the training. No recording allowed. Refunds minus credit card fees through September 1, 2021. Substitutions allowed after that. For registrations of 3 or more, get a $400 discount per student.
This three-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).
https://www.softwarecpr.com
SoftwareCPR® provides full service regulatory compliance and premarket submissions support for Medical Device Manufacturers including quality systems development, risk management - including for Health IT and Standalone Software, Human Factors and usability engineering, as well as hands-on validation services for Pharmaceutical and Medical Device companies. We also have extensive experience related to FDA enforcement action representation and negotiation and have served as expert witnesses.
Brian has over 35 years in the medical device industry as a biomedical and software engineer, various levels of management in medical device companies, and now is a Partner and General Manager of SoftwareCPR®. Brian has taught software validation courses at FDA, for AAMI, and both public and private courses for SoftwareCPR®. Brian helped create both AAMI TIR32 and AAMI TIR45 is a member of the UL Standards Technical Panel 5500, Remote Software Updates.
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