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Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.
There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

Course Details

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

Oriel STAT A MATRIX’s Goal

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

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