Postgraduate Diploma in Clinical & Regulatory Medical Writing – Medical Device

Programme Overview

This programme focuses on regulatory and clinical documentation specific to medical devices, aligned with global regulatory frameworks such as EU MDR, US FDA, and CDSCO.

Programme Curriculum

Introduction to Medical Devices

• Device definitions and classifications (Class I–III)
• Medical device lifecycle

Global Medical Device Regulations

• US FDA (21 CFR Part 812, 820)
• EU MDR 2017/745
• India – CDSCO & MDR 2017
• TGA, MHRA, PMDA

Clinical Trials in Medical Devices

• IDE
• Device vs drug trials
• Submission documentation

Core Documentation & Templates

• CSR
• IB
• Protocol
• CEP
• PMCF

Clinical Evaluation & Literature Reporting

• CER (MEDDEV 2.7/1 Rev. 4)
• Literature search & analysis
• CEP & PMCF preparation

Post-Market Documentation & Hands-On Practice

• SSCP writing
• Peer review & audit readiness
• Mock regulatory submission

Learning Outcomes

• Develop regulatory-compliant medical device documents
• Conduct literature reviews
• Prepare CER, CEP, PMCF

Eligibility: Graduates in any discipline

Programme Duration: 3–6 months

Programme Mode: Online