Brian Pate to Teach QSS Course – April 2025

SoftwareCPR® Partner and General Manager, Brian Pate, will teach the #aami QSS (Quality System Software) course on April 23rd and 24th, 2025. This course will be hosted by https://www.aami.org/ and runs from 9:00 am EDT to 6:00 pm EDT each day.

What is QSS?

QSS is all of that software, that is not part of the product, but is used in quality system activities or manages quality system records. Examples near and dear to software teams to consider:

  • Software requirements management tool
  • Software design tools that generate code
  • Automated software testing tools
  • Software compilers, linkers, and loading tools
  • Modeling tools
  • Data annotation and management systems
  • Software defect tracking and management systems
  • Vulnerability scanning tools

Beyond the software development organization, other QSS might include:

  • Complaint handling systems
  • Manufacturing tools including Excel spreadsheets
  • Many others

The manufacturer is obligated to demonstrate the QSS is validated for its intended use and continues to maintain that validated state throughout its lifecycle. We hope to see you at the course.

Registration Information:

You can use the direct link below or if you have questions, just email mailto:office@softwarecpr.com or use the form at the end of this post.

Brian Pate will be one of the instructors for the AAMI QSS Course in April 2025. Direct link to AAMI registration: https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1YUW00000F954o

Some QSS related posts:

Software Validation of Cloud Based Tools

Design Tool Validation Training Examples MFG

Product Software Versus Tool Software

If you have questions regarding QSS whether regulatory, quality, or the use of purchased (or acquired) software systems to automate quality system processes or manage quality system records, contact us via this form or email at mailto: office@softwarecpr.com:

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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