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QA/RA Consulting, Auditing & Training

Medical Device Software Development Life Cycle 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 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.

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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

SkillsLab $2995

Course Code	Location	Class Begins	Class Ends	Daily Schedule	Course Delivery	Class Agenda	Registration
SLS	VIRTUAL DELIVERY (Eastern time - PM)	11 Nov 2025	14 Nov 2025	1:00PM - 5:00PM Eastern US Time	Virtual		REGISTER

GROUP DISCOUNT

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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
Impacts to legacy software

Introduction to the Software Development Life Cycle (SDLC)

Software development life cycle (SDLC) introduction
SDLC methodologies / models:
1. Waterfall
2. Agile
3. Scrum model
4. Kanban model
5. DevOps model
6. Lean model
7. V-model
8. Continuous integration and continuous delivery / deployment (CI/CD)
IEC 62304 overview

Exercise! Describe Your SDLC Model

IEC 62304 Walkthrough: Planning the Software Design

Software device description
Software devolopment plan
Software requirements analysis, software architectural design, and software detailed design
Risk-based approach to planning

Exercise! Create a Software Development Plan

Risk Management for Medical Device Software

Risk standards and guidances:
- ISO 14971:2019
- ISO / TR 24971:2020
- IEC/TR 80002-1
Risk management process
Risk planning, analysis, and evaluation
Risk controls
Usability engineering for software

Exercise! Explore Medical Device Recalls Database

Exercise! Conduct a Risk Assessment

SBOMs, Cybersecurity, and Threat Modeling

Software Bill of Materials (SBOM)
Vulnerability exploitability exchange (VEX), known exploitable vulnerabilities (KEV), common vulnerabilities and exposure (CVE)
Cybersecurity
Threat modeling

Exercise! Benefits and Limitations of SBOM Types

IEC 62304 Walkthrough: Managing Software Configuration and Change Control

IEC 62304 configuration management requirements
Traceability considerations
Configuration management
Defect and issues management
Phase gate / design reviews

Exercise! Your Configuration and Change Management Process

IEC 62304 Walkthrough: Software Testing

Software testing and release requirements
Verification
Validation: key elements

Exercise! Create Verification and Validation Methods for Requirements

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.

Explain the impact of SBOMs, cybersecurity, and threat modeling to the SDLC

Manage software configuration and change control, as well as 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 is a fundamental course 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

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