AI systems in Regulatory and quality for Medical Devices

AI Systems in Quality & Regulatory Affairs

24 – 26 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?

Stay Ahead of the Curve

Understand how AI is transforming regulatory intelligence, submissions, and quality systems before it becomes the new compliance baseline.

Turn Automation into Advantage

Learn practical ways to integrate AI tools into QMS, audits, and documentation processes — saving time while improving consistency and oversight.

Decode Regulator Expectations

Gain insider insights on FDA and EU perspectives, ISO 42001, and emerging standards shaping the governance of AI in regulated environments.

Future-Proof Your Expertise

Build the competence and confidence to lead AI adoption in QA/RA roles, positioning yourself as a trusted voice in the next era of compliance and quality.

OUR ONLINE TRAINING EXERIENCE INCLUDE

Live, Interactive Format

Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.

Full Access via Client Zone

All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.

Certificate of Completion

Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.

LEARNING OBJECTIVES

Evaluate Automation Opportunities

Assess how AI-driven tools can improve efficiency and consistency across compliance and auditing processes

Understand AI Applications in QA/RA

Identify where and how AI technologies are transforming regulatory intelligence, submissions, and quality systems

Interpret Regulatory Expectations

Understand FDA, EU, and ISO 42001 perspectives on the use and governance of AI in regulated environments

Apply Risk and Governance Frameworks

Learn how to manage transparency, accountability, and ethical considerations in AI-enabled quality systems

Leverage Data for Smarter Decisions

Use AI insights for trend detection, predictive audit planning, and risk-based prioritization

Develop Future-Ready Skills

Strengthen the competencies needed to confidently lead AI adoption within regulatory and quality functions

WHO IS THIS TRAINING FOR?

Regulatory Affairs

Quality Assurance and Control

Device Engineering & Manufacturing

NB Reviewers

KEY TOPICS

Applying machine learning to enhance QMS processes and CAPA management

How AI transforms regulatory intelligence through automation and real-time insight

Leveraging predictive analytics for smarter, risk-based auditing and inspections

Ensuring governance, trust, and compliance with ISO 42001 and transparency principles

Developing the future-ready skills needed to lead AI adoption in QA and RA

TRAINER

James Pink

Meet James Pink — a seasoned regulator and recognized authority in quality and risk management for medical devices. With over 25 years of experience, he played a key role in establishing one of Europe’s leading notified bodies. During the COVID-19 pandemic, he was also responsible for scaling up the UK’s national ventilator effort.

TESTIMONIALS

Regulatory Manager, CSL

James' knowledge is impressive and it was very helpful to understand the backgrounds and sources/references for the different topics.

Senior Device Engineer, Novo Nordisk

James has great knowledge and in his presentation and his answers he always refered to guidelines, regulations and standards..

Product Manager, Bbraun

Brilliant course which I would highly recommend.

PAST PARTICIPANTS