Course overview

RAC-Devices Study Guide (2027)

Prepare for the RAC-Devices exam with a structured digital study guide aligned with the 2027 RAC-Devices Candidate Guide. Build your understanding of medical device and IVD regulation through clear explanations, practical examples, revision summaries and editable worksheets.

Explore all four exam domains, with professional ethics integrated throughout.

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RAC-Devices Study Guide (2027) Overview

Develop the knowledge and regulatory judgement needed for your RAC-Devices preparation with this self-paced study resource from RegTech Institute.

The 2027 edition covers:
-Domain I: Strategic Planning
-Domain II: Design and Development
-Domain III: Process for Licensing, Registration and Renewals
-Domain IV: Post-Market Activities

Study US FDA, EU MDR/IVDR and globally applicable regulatory principles across the product lifecycle. Professional ethics, confidentiality and patient safety are addressed throughout the guide.

Updated content includes IVD coverage, FDA QMSR, regulatory change assessment, submission and deficiency responses, contractual responsibilities and ongoing post-market compliance.

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— What's included

RAC-Devices Study Guide (2027) Features (Built for Exam Success)

Start strong on your RAC Devices certification journey with focused, high-impact learning. 

  • Ten structured study-guide chapters.
  • Practical examples and original practice questions with answers and rationales.
  • Editable regulatory tools, templates and worksheets.
  • Glossary, standards references and revision facts.
  • Study planners, tracking logs and a task-coverage checklist.
  • A bonus post-market timelines section covering EU and FDA reporting requirements.

Study Guide Chapters

Why choose RegTech Institute

At RegTech Institute we make online learning easy. Our only concern is your education. Build your future right here.

Structured Learning

Follow a chapter-based approach that connects regulatory principles with practical decisions.

Practical and Self-Paced Study

Study around work and family commitments using digital chapters, revision summaries and editable resources.

Updated for 2027

Prepare using material revised against the 2027 Candidate Guide, with medical device and IVD content across the four domains.

Who should Enrol

  • Regulatory affairs professionals preparing for RAC-Devices.
  • Quality and compliance specialists developing their regulatory knowledge.
  • Clinical, product and development professionals working with medical devices or IVDs.
  • Learners seeking a structured introduction to device regulatory affairs.


Learners planning to sit the examination should check the official RAPS eligibility requirements.

Lesson series

Start Your RAC-Devices 2027 Preparation

Build your regulatory knowledge, practise decision-making and organise your revision with the RAC-Devices Study Guide (2027).

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