Medical Device Regulatory Affairs
Master Global Compliance. Ensure Patient Safety
Step into the world of International Medical Device
Regulation with this 6-month professional certificate program designed for
future regulatory leaders.
What You'll Learn
Module 1: Indian Medical Device
Regulations
Understand IMDR, forms, schedules, and the full licensing submission process.
Module 2: EU Medical Device Regulation
Deep dive into MDR 2017/745, UDI, EUDAMED, and Post-Market Surveillance.
Module 3: US FDA Regulations
PMA, 510(k), QMSR, De-Novo submissions, and labeling regulations.
Module 4: QMS & Risk Management
Learn ISO 13485, ISO 14971, PDCA cycle, and AI-based quality system frameworks.
Module 5: MDSAP & Audits
Prepare for international QMS audits, MDSAP frameworks, documentation &
country-specific requirements.
Module 6: Testing Facilities &
Standards
Gain knowledge in IVD standards, GLP compliance, and facility certification.
Module 7: On-the-Job Training
Case studies, audits, real-world documentation & dossier preparation.
Career Opportunities
1. Regulatory Affairs Specialist
2. Quality Assurance (QA) Executive
3. Regulatory Compliance Analyst
4. Clinical Evaluation and Documentation Associate
5. Medical Device Auditor
6. RA/QA Consultant for MedTech Startups
Why Enroll With Us?
Comprehensive Global Curriculum
Learn from Industry Experts
Real-World Practical Training
Career-Oriented Approach
Access to Regulatory Tools & Templates
Duration: 6 Months
Course Fee:
For Indian Nationals: INR 60,000 (Including GST)
For Others: USD 1,000
Mode: Offline
Eligibility:
Nationality: Any Nationality
Location:
AMTZ Campus, Visakhapatnam, Andhra Pradesh
🎓
Secure Your Seat Today!
last Date for Registration: 30th July 2025
Course
Starts: 1st September 2025
For More Information:
Mr. Nitturi Naresh Kumar
Scientist, IBSC
Mobile: 70130 28578 / 8897330990
Email:n.nareshkumar@ibsc-amtz.in
| S.No | Start Date | End Date | Total Amount (INDIA) | Total Amount (Foriegn) |
|---|---|---|---|---|
| 1 | 2025-07-07 | 2025-08-31 | 60,000 | 85,000 |
Copyright© 2021. Designed and Developed by AMTZ IT Team.
Live comments