Certification Course
Medical Device Vigilance Certification
Master post-market surveillance, incident reporting, EU MDR/IVDR regulations, ISO 14971 risk management, and CDSCO compliance. Build the skills the medical device industry demands.
2 Month Course Live Online Classes Industry Certificate
One-time enrollment fee
₹7,500
Duration
2 MonthsBatch Size
Small BatchesMode
Online Live ClassesCertificate
On CompletionPlacement
100% AssistanceRating
4.9 / 5Post-Market Surveillance (PMS)
EU MDR / IVDR Regulations
ISO 14971 Risk Management
Incident Reporting (MIR / FSCA)
Placement Assistance & Mock Interviews
Curriculum
What You'll Learn
A 2-month industry-aligned curriculum covering all aspects of medical device vigilance and post-market safety.
Module 1
Introduction to Medical Devices
- Classification of medical devices (Class I, II, III)
- Global medical device market and regulatory landscape
- Key regulatory bodies: CDSCO, USFDA, EU MDR, TGA
- Life cycle of a medical device — design to post-market
Module 2
Regulatory Frameworks
- EU Medical Device Regulation (MDR 2017/745) overview
- EU In Vitro Diagnostic Regulation (IVDR 2017/746)
- US FDA 21 CFR Part 803 & 806 — MDR and corrections
- India CDSCO Medical Device Rules 2017
Module 3
Post-Market Surveillance (PMS)
- PMS planning and systematic data collection
- PMCF (Post-Market Clinical Follow-Up) studies
- PMS reports vs. PSUR for medical devices
- Complaint handling and trend analysis
Module 4
Incident Reporting & Vigilance
- Definitions: serious incidents, field safety corrective actions
- Manufacturer Incident Report (MIR) writing
- FSCA and Field Safety Notices (FSN)
- Timelines for expedited and periodic reporting
Module 5
Risk Management
- ISO 14971:2019 — risk management for medical devices
- Risk analysis, evaluation, and control measures
- Residual risk acceptability and benefit-risk determination
- Risk management file documentation
Module 6
Career & Placement Preparation
- MDV job roles: Vigilance Officer, RA Executive, PMS Analyst
- Resume building for medical device industry
- Mock interviews with industry professionals
- Recruiter connects and placement assistance
Course Outcomes
- Handle medical device incident reports per global regulations
- Implement and maintain Post-Market Surveillance systems
- Apply ISO 14971 risk management principles confidently
- Navigate EU MDR/IVDR and CDSCO regulatory requirements
- Write Manufacturer Incident Reports (MIRs) and FSCAs
- Qualify for MDV analyst and vigilance officer roles
Who Is This For?
- B.E. / B.Tech (Biomedical, Mechanical, Electronics) graduates
- B.Pharm / M.Pharm graduates exploring medical device sector
- MBBS / BDS professionals interested in regulatory affairs
- Life sciences and biotechnology graduates
- Working professionals seeking to move into medical device vigilance
Not sure if this is right for you?
WhatsApp us and we'll guide you →FAQ
Frequently Asked Questions
Batch Starting Soon
Launch Your Medical Device Career
₹7,500 one-time fee. 2 months. 100% placement assistance. Limited seats — enroll now.
✉ medizeninstitutevigilance@gmail.com ·