PG Diploma in Medical Device Regulatory Affairs & Global Compliance

Course Duration : 6 Months

Mode : 100% Online (Live Interactive Sessions + Recorded Sessions + LMS Access)

Prepare for high-growth careers in the global Medical Device and MedTech industry with comprehensive training in Regulatory Affairs, Quality Systems, Risk Management, Technical Documentation, and Global Compliance.

Graduates, final-year students, and working professionals from Life Sciences, Biotechnology, Biomedical Sciences, Biomedical Engineering, Pharmaceutical Sciences, Nursing, Allied Health Sciences, Mechanical Engineering, Medical Electronics, Electronics & Instrumentation, and related disciplines.

The Post Graduate Diploma in Medical Device Regulatory Affairs & Global Compliance is a career-oriented programme designed to prepare learners for regulatory and quality careers within the rapidly expanding global Medical Device industry. As regulatory requirements continue to evolve across India, the United States, Europe, and other international markets, organisations increasingly require professionals with expertise in medical device regulations, quality management systems, technical documentation, risk management, and compliance. This programme combines regulatory theory with practical documentation exercises, industry case studies, workshops, and a live capstone project to help learners become job-ready for entry-level regulatory affairs and quality assurance roles.

Programme Highlights

100% Online Learning
Live Interactive Classes
Recorded Sessions
LMS Access
Industry Expert Faculty
Practical Regulatory Documentation
ISO Documentation Workshops
Capstone Project
Mock Regulatory Audits
Resume Building
LinkedIn Optimization
Mock Interviews
Placement Assistance

Understand Global Medical Device Regulations
Navigate CDSCO, US FDA & EU MDR
Prepare Regulatory Documentation
Apply ISO 13485
Conduct Risk Management using ISO 14971
Prepare Clinical Evaluation Documentation
Develop Global Regulatory Strategies
Support Post-Market Surveillance
Build Industry-Ready Documentation Skills

Module I – Introduction to Medical Devices & Regulatory Affairs

Module II – Indian Medical Device Regulations (CDSCO)

Module III – Quality Management Systems (ISO 13485)

Module IV – Risk Management (ISO 14971)

Module V – Global Regulatory Frameworks (US FDA & EU MDR)

Module VI – Technical Documentation & Clinical Evaluation

Module VII – Post-Market Surveillance & Global Market Access

Module VIII – Digital Health & Emerging Regulations

Regulatory Affairs Associate
Regulatory Affairs Executive
Medical Device Regulatory Specialist
Quality Assurance Executive
Regulatory Documentation Specialist
Clinical Affairs Associate
Compliance Executive
Product Compliance Associate
Regulatory Intelligence Associate
Technical Documentation Executive

Capstone Project

Develop a complete regulatory strategy covering Device Classification, CDSCO Registration, US FDA, EU MDR, Technical Documentation, Risk Management, Clinical Evaluation, Post-Market Surveillance and Global Commercialization.