RA Mastery
Regulatory Affairs Mastery
Flagship 40–50 hour self-paced regulatory affairs program
About this course
Course overview
A beginner-to-advanced regulatory affairs program covering EU MDR, US FDA, India MDR, ISO standards, technical documentation, clinical evaluation, risk management, labelling & UDI, post-market surveillance, AI/SaMD, audits, real industry case studies and career mastery — across 17 in-depth modules and ~150–200 lessons.
At a glance
Key information
17 modules
Regulatory
Beginner → Advanced
40–50 hours (self-paced)
80%
Free, instant
Students, QA/RA professionals, engineers, manufacturing, R&D and auditors who want a complete, career-grade RA curriculum.
Outcomes
What you'll learn
- Understand introduction to Regulatory Affairs
- Understand medical Device Classification
- Understand european Regulatory System (MDR 2017/745)
- Understand uS FDA Regulations (21 CFR Part 820 / QMSR)
- Understand india Regulatory Framework (MDR 2017)
- Understand iSO Standards Overview
- Understand technical Documentation
- Understand clinical Evaluation
Curriculum
Course curriculum
17 modules · Tap any module to expand and preview lessons.
Benefits
Why take this course
Navigate global regulations
Decode regional regulatory frameworks and learn what authorities expect from manufacturers.
Stay audit-ready
Understand the exact clauses and expectations auditors and regulators check during inspections.
Boost your career
A recognised certificate of completion that you can add to your CV and LinkedIn profile.
Plain-language modules
Complex requirements broken into bite-sized, easy-to-remember lessons with examples.
Free assessment & certificate
Take the timed exam and earn a personalised, verifiable certificate at no cost.
Who it's for
Target audience
- Students
- QA/RA professionals, engineers, manufacturing
- R&D and auditors who want a complete, career-grade RA curriculum
Included
What's included
17 plain-language modules
Bite-sized lessons with examples, memory aids and key terms.
Timed assessment
Multiple-choice exam with 80% pass mark. Retake anytime.
Verifiable certificate
Personalised PDF with a unique verification code — shareable on LinkedIn.
Downloadable resources
Reference material and attachments available inside modules.
Lifetime access
Learn at your own pace — revisit modules whenever you need to refresh.
Aligned to standards
Content mapped to internationally recognised medical device standards and regulations.
FAQ
Frequently asked questions
More questions? Visit the full FAQ.
Free · Lifetime access
Exam + certificate included