Programme Overview
Build expertise in clinical and regulatory documentation for medical devices aligned with EU MDR, US FDA, and CDSCO frameworks.
This programme focuses on hands-on regulatory writing, clinical evaluations, post-market documentation and global submission readiness.
Online Mode
3–6 Months
Any Graduate
Regulatory Projects
2000+
Learners
Learners
80+
Hiring Partners
Hiring Partners
95%
Career Support
Career Support
Programme Curriculum
Medical Device Fundamentals
Device classifications, lifecycle & regulatory pathways.
Global Regulations
FDA 21 CFR, EU MDR 2017/745, CDSCO MDR.
Device Clinical Trials
IDE submissions & device trial workflows.
Core Documentation
CSR, IB, Protocol, CEP & PMCF.
Clinical Evaluation
CER (MEDDEV 2.7/1 Rev.4) & literature reviews.
Post-Market Surveillance
SSCP writing & audit readiness.
Mock Submissions
Hands-on regulatory submission practice.
Career Preparation
Real-world projects & placement guidance.
Learning Outcomes
✔ Regulatory-compliant device documentation
✔ Literature review & CER preparation
✔ CEP & PMCF development
✔ Post-market documentation skills
Become a Medical Device Regulatory Writer
Gain industry-ready expertise in global medical device documentation.
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