Our General Manager, Brian Pate, will be co-teaching the 3-Day AAMI Software Validation course on October 27-29, 2026 from 9:00 am to 6:00 pm Eastern Time.  This class will ground you in all the relevant regulations, standards and guidance and help you understand how risk, cybersecurity, cloud computing and mobile apps impact the medical device software space. It will also challenge you with real-life exercises to give you experience in determining the different classes of software and the activities required for developing and validating that software.

Covers:

• Regulations – 21CFR820, EU MDR/IVDR
• Standards – ISO 13485, ANSI/AAMI/IEC 62304:2006/A1:2015, ISO 14971, ANSI/AAMI/IEC80002-1:2009
• FDA Guidance – General Principles of Software Validation, IMDRF SaMD, Mobile Medical App, Cybersecurity Premarket, Cybersecurity Post Market,AAMI TIR57 – Medical Device Security, Premarket Submissions from Medical Devices with Software
• Explain the relationship between FDA and MDR Medical Device Classes, Software Safety Classes, and Software Development and Validation Activities.
• Understand the required Activities for Developing and Validating Medical Device Software
• Understand the FDA and EU Regulatory Submission requirements for the various classes of software

Who Should Attend

Instruction is geared to professionals with various experience in one or more of the following areas: Software Engineering, Software Quality, Regulatory or Compliance.

Attendees will be interested in staying current with all the new software guidance and standards from the perspective of Medical Device Software not Production and Quality Systems Software.

Typical attendees will consist of professionals who work in Software Engineering, Verification, Quality, Regulations, and/or Compliance.

Materials

Fee includes a digital copy of the ANSI/AAMI/IEC 62304 standard, versions of the PowerPoint presentations and case studies, pertinent FDA documents, and additional references.

 

You can register for the course at this link: https://store.aami.org/s/community-event?id=a1YUW00000gyPzV2AU