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Medical Device Non-Product Software Validation Training

If you’re using software to automate a process that is required by FDA, there is a good chance you’ll be required by FDA to validate that software to demonstrate that it accurately, reliably, and consistently meets the requirements for its intended use. ISO 13485 has similar requirements. 

Non-product software is used across the full life cycle of a medical device and includes software used in the manufacturing process (e.g., software embedded in machine tools and statistical process control software); in design and development processes (e.g., CAD, CAM); software used to automate any part of the quality process (e.g., complaint-handling software); and software related to electronic records and signatures for documents required by regulation. 

In this course, using hands-on exercises and case studies, you will learn how and when to effectively implement a non-product software validation program for medical devices that meets FDA and ISO requirements.  We will also cover the role of risk management in non-product validation.

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Course Details

What You Will Learn

At the end of this workshop, you will be able to:

  • Distinguish non-product software (NPS) from product software
  • Describe NPS validation requirements found in ISO 13485:2016 and 21 CFR 820.70
  • Describe the overall life cycle of NPS software in the quality management system (QMS)
  • Develop and/or evaluate a validation process for NPS
  • Determine effort of NPS validation based on a risk assessment
  • Plan, define, and implement validation of NPS for deployment of NPS
  • Describe the use of system design and requirements in NPS validation
  • Document test protocols, testing, verification activities, and validation activities
  • Describe validation needs for low-, medium-, and high-risk NPS
  • Describe how to document NPS validation results
  • Explain maintenance, changes, and retirement of NPS

Who Should Attend

Quality engineers, validation engineers, Computer Software Validation (CSV) personnel, IT personnel, test engineers, personnel in supplier quality, production/manufacturing/operations quality, developers and users of non-product software, and project managers in these areas.

  • Virtual Half-Days

  • In-Person Full-Days

  • CEUs


Virtual Session Details

Virtual Session Details

The learning objectives and topics covered during virtual instructor-led training (VILT) are the same as those for the in-person version of the course. As well, all VILT classes are taught by the same experienced team of instructors you’ve come to expect from Oriel STAT A MATRIX. To accommodate the VILT format, classes are delivered at a pace well suited to virtual instruction, and the structure of class workshops and exercises has been modified to work best in the virtual environment. Each virtual session is a combination of subject matter expert and group discussions, interactive whiteboards, polls, and chat rooms that help students with small group exercises, making this an engaging, interactive learning experience.

Online Training Schedule

  • This class is delivered across 4 consecutive business days.
  • Classes run daily 1:00 - 5:00 p.m. Eastern time

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

  • PC MAC Computer

    PC or MAC Computer

  • Reliable Internet

    Reliable Internet

  • Video Webcam

    Video Webcam

  • Headset or Earbuds

    Headset or Earbuds

  • Quiet Setting

    Quiet Setting

  • Two Monitors Recommended

    Two Monitors

Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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