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QA/RA Consulting, Auditing & Training

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 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)	03 Mar 2025	06 Mar 2025	1:00PM - 5:00PM Eastern US Time	Virtual		REGISTER
SLS	VIRTUAL DELIVERY (Eastern time - PM)	11 Nov 2025	14 Nov 2025	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:

Traditional waterfall
Agile
V-Model
Artificial intelligence (AI)
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

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

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

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