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Medical Device Software Development Life Cycle Training

Available as a virtual instructor-led seminar.

The software development life cycle (SDLC) covers all aspects of software from development to validation and change control. This course provides an in-depth look at the SDLC, using IEC 62304:2006 as a basis for the course discussions.

Exercises within the course provide opportunities for practical application of the concepts being learned. Learn how to map these phases, processes, and deliverables to US and global regulatory requirements/standards.   

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Course Detail

What Will You Learn

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

  • Describe the software development life cycle, including examples of commonly used SDLCs
  • Identify and describe SDLC support activities
  • Plan the design of medical device software
  • Perform risk management activities as they pertain to software
  • Manage software configuration and change control
  • Manage defects and issues in medical device software
  • Describe verification and validation of medical device software
  • Identify common tasks included in verification and validation of medical device software

Who Should Attend

This course is intended for those who need to gain an understanding of the application of software regulations and guidance in the context of the SDLC. This includes software developers and industry professionals involved with non-regulatory functions associated with software such as:

  • Software QA Engineers
  • Program Managers (managing software)
  • Software Test Engineers
  • Scrum Master (lead of Agile development)
  • Solution Architects

 

  • Virtual Half-Days

    4
  • In-Person Full-Days

    2
  • CEUs

    1.6

Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX virtual instructor-led training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

The learning objectives and topics covered during VILT are the same as those for the in-person version of the course. 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.

Online Training Schedule

This class is delivered across 4 consecutive days. Sessions run daily from 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

See course dates to find / register for a virtual online session of this course.

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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