Medical Device Regulatory Affairs Training Courses

• Trainer Expertise — All our instructors are industry veterans, having worked with device manufacturers, notified bodies, and regulatory agencies.
• Practical Focus — Case studies, group workshops, and real-world examples ensure you understand how to apply theory in your projects.
• Global Regulatory Coverage — Courses include content on UK MDR / UKCA, EU MDR / IVDR, US FDA device/IVD regulation, and harmonisation efforts.
• Post-Learning Support — Access to reinforcement materials, learning reference guides and continuous updates helps you retain and apply your learning.
• Flexible Delivery Formats — Choose live online, hybrid, or on-demand formats to suit your team or individual needs.

In our medical device & IVD training portfolio, topics include:

• EU MDR, IVDR and US FDA
• 510(k) process and requirements, plus De Novo and Premarket Approval (PMA)
• Classification of device and regulatory routes to market in the EU, UK and US
• ISO 13485 & quality management systems for devices
• Risk management & hazard analysis (ISO 14971)
• Clinical evaluation, evidence generation, and post-market clinical follow-up (PMCF)
• UDI, labelling, regulatory registration strategies across regions
• Software as a Medical Device (SaMD), including AI/ML considerations
• Biocompatibility, sterilisation, validation & verification
• Post-market surveillance, vigilance, CAPA, complaint handling
• Combination products (drug/device) – regulatory challenges and pathways

Our training courses are ideal for:

• Regulatory Affairs / QA / Compliance professionals in medical device & IVD firms
• Design / R&D / Engineering leads working on product development
• Clinical affairs, validation, or quality engineers seeking regulatory alignment
• Device startups wanting to ensure compliance from the outset
• Beginners to medical devices and/or experienced professionals
• Commercial roles such as marketing, business development and strategy.

Comprehensive Medical Device Training for Global Compliance

Staying ahead of evolving medical device regulations is critical. Our training programmes cover core regulations such as EU MDR 2017/745 and IVDR 2017/746, including conformity assessment, technical documentation, and post-market requirements. We also cover UK CA / UK MDR transitions, and US FDA pathways to help you navigate multi-region strategy.

Clinical Evidence, Software & Post-Market Vigilance

Regulators expect strong clinical evaluation and evidence. You’ll dive into clinical investigations, post-market clinical follow-up, complaint handling, vigilance, and CAPA strategies. Given the rise of software-based and AI-driven devices, specific modules cover SaMD, cybersecurity, usability engineering and regulatory requirements for digital health.

Device Lifecycle & Change Management

Devices don’t remain static. We explore how to manage design changes, variations, upgrades, and end-of-life transitions without jeopardising compliance. You’ll also see how UDI, labelling, and traceability systems support lifecycle management.

Benefits & Outcomes for Your Team

Participants leave able to:

• Prepare high-quality technical documentation and submissions
• Understand regulatory expectations across regions
• Align engineering, quality and RA teams on compliance strategy
• Mitigate risk, reduce regulatory delays and audit findings
• Maintain compliance across device lifecycles in changing regulatory environments