18

Mar

2025

Brian Pate to Teach QSS Course – April 2025

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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 Pate

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.

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering: June 24-26, 2025 (Boston, MA)

Multiple participants from the same company: If you register 5 or more from the same company before March 15, 2025, receive a special discounted registration of $1999 per person. These registrations may be transferred to another person at any time. Email training@softwarecpr.com to register and secure the TEAM discount.

For private, in-house courses, please contact us.

Email training@softwarecpr.com for more info.

Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

Agile principles that align well with medical
Backlog management
Agile risk management
Incremental and iterative software development lifecycle management
Frequent release management
And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

Americas: 11-13 February 2025
EU/Eastern Europe/Middle East/Africa/Atlantic/eastern South America: 18-20 February 2025
Southern Central Northeastern Pacific: 24-26 February 2025

See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering: TBD