Course Dates 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 1.5
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