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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.   

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.

Location Start Date Days Cost Public Course Private
VIRTUAL DELIVERY (Eastern Time) 07/19/2022 4 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (Eastern Time) 11/29/2022 4 $2995.00 Add to Cart CONTACT US

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

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:

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

VIRTUAL CLASS TIMES Close

Public virtual seminars run daily from 1:00-5:00 p.m. ET. Seminars run on Eastern Time unless otherwise noted in the Location field.

Auditor classes that require a final exam start at 11:30 a.m. on the last day to administer the final exam.

For more information download the virtual course agenda (close this window and navigate to the top of the course page) or Contact Us.

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