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Medical Device Software Development, Verification, and Validation Training (IEC 62304 and ISO 13485:2016)

Learn how to apply US and international regulatory requirements and standards for the design and validation of medical device software, including IEC 62304, IEC 80001, and ISO 13485 software requirements.

This class is available virtually.

US FDA and international regulatory standards relating to software are evolving and becoming more stringent. This makes the process of validation and verification (V&V) even more important – not only to comply with regulations, but also to ensure patient safety.

In this class, you will learn how to apply FDA and international regulatory requirements and standards (IEC 62304 and ISO 13485:2016 software requirements) for the design and validation of medical device software, including embedded software, software as a medical device (SaMD), and QMS software.   

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Course Detail

What You Will Learn

At the conclusion of this workshop, you will be able to:

  • Understand key regulations/standards/guidance, including IEC 62304, AAMI TIR36, ISO/TR 80002-2, and AAMI TIR45.
  • Identify software development life cycle (SDLC) phases, processes, and deliverables.
  • Map these phases, processes, and deliverables to US and global regulatory requirements/standards.
  • Describe how Agile software development aligns with regulatory expectations for software validation.
  • Identify requirements for validating nonproduct software (QMS software).
  • Describe how to apply risk management principles and perform risk-based software tool validation.
  • Assess real-world lessons learned and identify the benefits of an SDLC, including time to market.
  • Understand FDA design control guidance, including traceability and design review requirements.
  • Evaluate and recommend testing-level strategies (unit, integration, system, user).
  • Understand methods development and documentation requirements.
  • Create a plan for configuration and change management, including defects and issues management.
  • Describe documentation requirements for FDA and EU premarket submissions.

Who Should Attend

Recommended for computer system/software users, mid-level managers, software developers/engineers/testers, product managers, regulatory personnel, and quality assurance professionals in FDA-regulated fields.

  • Virtual Half-Days

  • In-Person Full-Days

  • CEUs


Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX virtual instructor-led training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

The learning objectives and topics covered during VILT are the same as those for the in-person version of the course. To accommodate the VILT format, classes are delivered at a pace well suited to virtual instruction, and the structure of class workshops and exercises has been modified to work best in the virtual environment.

Online Training Schedule

This class is delivered across 4 consecutive days. Sessions run daily from 1:00-5:00 p.m. (Eastern Time).

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

  • PC MAC Computer

    PC or MAC Computer

  • Reliable Internet

    Reliable Internet

  • Video Webcam

    Video Webcam

  • Headset or Earbuds

    Headset or Earbuds

  • Quiet Setting

    Quiet Setting

  • Two Monitors Recommended

    Two Monitors

See course dates to find / register for a virtual online session of this course.

Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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