GMED North America’s Training Center

Medical Device Software Lifecycle per IEC 62304

Understand the software development and validation requirements

Save on tickets with Early Bird Special, Client and Bundle Discounts**

3 half-days of training | Virtual Classroom | $1900 pp

April 22-24, 2025

About the training

GMED North America has created a 2-day training session, to equip medical device manufacturers with the right strategy to ensure their medical device software processes/documentation can withstand heightened scrutiny from NBs.

This comprehensive 2-day course covers the processes defined in IEC 62304 including software development, maintenance, risk management, configuration management, and problem resolution. It includes various aspects of planning and documentation of software development, software requirements, software architecture, software safety classification, software testing, and addressing SOUP/OTS software.

The course provides an overview on European and U.S. regulatory requirements for software development and validation, standard documents or guides useful for declaring compliance with regulatory requirements, and implementation of quality management principles for medical device software development.

Ali Homaida Senior Compliance Engineer – Active Medical Devices at 601 Consultancy Ltd

Ali Homaida is an accomplished IEC 60601-1 Compliance Engineer, Consultant, Product Reviewer, and Trainer in the medical device industry.

With a background in biomedical engineering, he has worked with test houses in compliance assessment of electrical medical devices including safety testing, risk management files evaluation, usability engineering, and medical devices software.

Who Should Attend

Experts working with software development, such as R&D engineers, quality assurance department, and internal/external auditors of software development.
Auditors and Product Reviewers for Active Medical Devices

Learning Objectives

Identify European and U.S. regulatory requirements for software development and validation
Identify standard documents or guides useful for declaring compliance with regulatory requirements
Implement quality management principles for medical device software development

Educational Resources

Presentations
Practical working sessions
Course evaluation

Check out the Program

Day 1-3

Program

Regulations: regulatory requirements for software development and validation, Overview of American and European requirements.

Presentation of standards and guides available to manufacturers to meet regulatory requirements Software development planning.

Requirements definition (system input data) Software design and construction.

Implementation of a risk management process applied to software testing.

Configuration and cybersecurity management.

Software maintenance and troubleshooting: how to apply a corrective and preventive action process?

Course evaluation, summary and conclusions.

Plan a Training Today

We offer a variety of training courses and we focus on your challenges and provide our attendees with a clear “take-home” value.