3 – 5 February 2026
TRAINING TIMES
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
Learn how to evaluate product design, manage changes, and meet essential safety and performance requirements
Understand the role of usability in compliance and how it impacts product safety, performance, and regulatory approval
Work through case studies and examples to apply design control and risk management principles directly to your own projects
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.
Learn how to assess design against essential safety and performance requirements
Gain clarity on EU and US regulations for drug–device combinations, including ISO 13485:2016 and CFR21
Understand expectations for design control, design changes, and post-approval requirements
Identify how risk analysis and controls impact QMS practices and regulatory compliance
Recognise the importance of usability in ensuring safe and effective product performance
Designed for professionals who want to enhance their expertise and advance their careers
Health Sciences and Medical Devices Consultant
James Pink has over 25 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assuranceprograms for active and non-active implantable and combination products. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.
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