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Software Verification and Validation for Medical Device Manufacturers

This comprehensive full-day course covers the critical topics of software verification and validation. Concepts and practices applicable to the following key areas are presented:
  • Software-based medical devices
  • Software-based manufacturing and production equipment
  • Quality System software (e.g., CAPA and Complaint Handling Systems, etc.)

Based on the latest AAMI technical reports, FDA guidance documents and over 20 years of experience working with medical device companies, this course provides practical recommendations for applying software verification and validation techniques in a manner that is both compliant and cost-effective.

Examples of procedures needed to comply with the software validation requirements of the FDA Quality System Regulation and the FDA General Principles of Software Validation Guidance document are presented. This course includes in-depth discussions of software verification techniques, such as peer reviews, and software validation techniques that can significantly improve the effectiveness of your validation testing.

In addition to medical device software, validation of software development tools, 3rd party and off-the-shelf (OTS) software, manufacturing and Quality System software is also discussed.

This course can be tailored to the specifics of your product development process. As a result, you can immediately identify areas of potential regulatory exposure. By applying the guidance and suggestions in the course, you can minimize or eliminate any potential exposure and improve the effectiveness of your software verification and validation activities.

Topics covered include:

  • Regulations, Guidance, and International Standards
  • Software Verification Techniques
  • Techniques for Effective Peer Reviews
  • Software Validation Techniques
  • Validation Levels, Methods, and Types
  • Validation Planning
  • Validation Metrics
  • Common Problems
  • Validation of Software Tools, Off the Shelf, and 3rd Party Software
  • Validation of Quality System Software and software-based process equipment

To help reinforce critical skills related to software verification, an interactive exercise is included.


This course can be tailored to meet your specific needs. By reviewing your Quality Manual and relevant SOPs, an assessment of your current Quality System and how it meets (or doesn't meet) the regulations and standards can be provided as part of the course.
Software Verification and Validation for Practitioners and Managers