Loading ...
oriel

Medical Device Software Development Life Cycle (SDLC) and IEC 62304 Training

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. If you need a foundational course on medical device software regulations and standards, consider this course instead.

Compare Classes

Brief Overview of This Medical Device SDLC and IEC 62304 Class

SkillsLab Class ?

Class Content

In-Depth

Class Duration

4 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEUs)

1.6

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 2 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming SDLC and IEC 62304 Training Courses

SkillsLab $2995

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
SLS VIRTUAL DELIVERY (Eastern time - PM) 21 Oct 2024 24 Oct 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
SLS VIRTUAL DELIVERY (Eastern time - PM) 09 Dec 2024 12 Dec 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

What We Cover in This Intensive Class on Medical Device SDLC

This course provides an in-depth look at the software development life cycle, using IEC 62304 as a foundation for course discussions. The software development life cycle covers all aspects of software from development to validation and change control. The activities within the course provide practical applications of the concepts being learned. All exercises and discussions within the course are framed within the US and global regulatory requirements and standards.

Course Overview
SkillsLab Class

Software Regulatory Background

  • High-level summary of global regulations
  • Key guidelines and standards
  • Review of IEC 62304
  • Impacts of the regulatory requirements and standards on legacy software

Introduction to the Software Development Life Cycle (SDLC)

  • Software development life cycle (SDLC) introduction
  • SDLC examples:
    1. Traditional waterfall
    2. Agile
    3. V-Model
    4. Artificial intelligence (AI)
    5. Continuous integration and continuous delivery / deployment (CI/CD)
  • Describe the SDLC used in your organization
Exercise! Describe Your SDLC Model

IEC 62304 Walkthrough: Planning the Software Design

  • High-level requirements
  • Software development plan
  • Risk-based approach to planning
  • Examples of planning for low-risk and high-risk devices
Exercise! Create a Software Development Plan

IEC 62304 Walkthrough: Risk Management for Software

  • ISO 14971
  • Hazard analysis
  • Risk evaluation
  • Risk controls
  • Cybersecurity considerations
  • Usability engineering for software
  • Risk tools as they relate to software
  • Create a Failure Mode and Effects Analysis (FMEA) for a fictitious product
Exercise! Develop a Failure Mode and Effects Analysis (FMEA) for a Software Product

IEC 62304 Walkthrough: Managing Software Configuration and Change Control

  • Configuration management tools
  • Traceability considerations
  • Versioning control
  • Software bill of materials (SBOM)
  • Software issue tracking
  • Change request activities
  • Software maintenance and problem resolution
  • Software problem reports
  • Problem resolution process
Exercise! Describe Your Configuration and Change Management Process

IEC 62304 Walkthrough: Software Testing

  • Verification
  • Initial unit testing
  • Integration testing
  • System testing
  • Software release testing
  • Validation
Exercise! Create Verification and Validation Methods for Requirements

Lessons Learned

  • Best practices
  • Audit preparation
  • Warning letter examples
Exercise! FDA Warning Letters
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab

Describe the software development life cycle (SDLC), 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

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 software development life cycle (SDLC). This includes software developers and industry professionals involved in nonregulatory functions associated with software, such as software QA engineers, program managers (managing software), software test engineers, scrum masters (lead of Agile development), solution architects, usability engineers, and cybersecurity specialists.

  • Software QA Engineers
  • Program Managers
  • Solution Architects
  • Usability Engineers
  • Cybersecurity Specialists

 

 

© Oriel STAT A MATRIX. All Rights Reserved. Site Map Privacy and Legal