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Medical Device Software Development, Verification, and Validation Training

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 US and international regulatory requirements and standards for the design and validation of medical device software, including embedded software, software as a medical device (SaMD), and QMS software.

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.800.472.6477  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
San Diego, CA 07/22/2019 2 $2495.00 Add to Cart CONTACT US
Minneapolis, MN 09/16/2019 2 $2495.00 Add to Cart CONTACT US
Boston, MA 11/18/2019 2 $2495.00 Add to Cart CONTACT US
Chicago, IL 01/13/2020 2 $2495.00 Add to Cart CONTACT US
Edison, NJ 03/02/2020 2 $2495.00 Add to Cart CONTACT US

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.

Number of Days: 2
CEUs: 1.5

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