Design Control and Risk Management For Combination Products
3 – 5 February 2026
1 850 €
TRAINING TIMES
13:00 - 16:00 Vienna
12:00 - 15:00 London
07:00 - 10:00 New York
04:00 - 07:00 Los Angeles
WHY SHOULD YOU ATTEND?
Master Global Regulatory Requirements for Combination Products
Gain clarity on EU and US frameworks, including ISO 13485:2016, CFR21 Part 4, and Part 820.30, and how they apply to drug–device combinations
Build Confidence in Design Control and Risk Management
Learn how to evaluate product design, manage changes, and meet essential safety and performance requirements
Apply Human Factors and Usability Engineering
Understand the role of usability in compliance and how it impacts product safety, performance, and regulatory approval
Translate Theory into Practice with Real-World Examples
Work through case studies and examples to apply design control and risk management principles directly to your own projects
OUR ONLINE TRAINING EXERIENCE INCLUDE
Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.
Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.
LEARNING OBJECTIVES
Evaluate Product Design for Compliance
Learn how to assess design against essential safety and performance requirements
Understand Global Regulatory Requirements
Gain clarity on EU and US regulations for drug–device combinations, including ISO 13485:2016 and CFR21
Apply Design Control Principles
Understand expectations for design control, design changes, and post-approval requirements
Integrate Risk Management into Quality Systems
Identify how risk analysis and controls impact QMS practices and regulatory compliance
Incorporate Human Factors and Usability Engineering
Recognise the importance of usability in ensuring safe and effective product performance
WHO IS THIS TRAINING FOR?
Regulatory Affairs
Quality Assurance and Control
Device Engineering & Manufacturing
Research & Development
KEY TOPICS
Risk management and design control fundamentals
Risk Analysis, Evaluation And Controls
Standards and regulations
Usability engineering
Design Changes
Design Controls Requirements
Post-approval
TRAINER
PAST PARTICIPANTS
Design Control and Risk Management For Combination Products
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
