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
Recognized by IBSC
Career-Oriented Approach
Access to Regulatory Tools & Templates
Duration:
6 Months
Course Fee: INR 60,000
(Including GST)
Mode: Offline
Eligibility:
Any Degree in Science, Pharma and Engineering
Nationality: Any Nationality
Location:
AMTZ Campus, Visakhapatnam, Andhra Pradesh
🎓
Secure Your Seat Today!
Course
Starts: 1st August 2025
For More Information:
Mr. Nitturi Naresh Kumar
Scientist, IBSC
Mobile: 8897330990
Email:n.nareshkumar@ibsc-amtz.in
| S.No | Start Date | End Date | Total Amount (INDIA) | Total Amount (Foriegn) |
|---|---|---|---|---|
| 1 | 2025-05-30 | 2025-08-31 | 60,000 | 750 |
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