Certificate in ISO 14971:2019 Risk Management for Medical Devices

A Certificate in ISO 14971:2019 Risk Management for Medical Devices provides specialized training on the application of ISO 14971:2019, the internationally recognized standard for managing risks associated with medical devices throughout their lifecycle. This certification equips professionals with the knowledge to systematically identify hazards, analyze and evaluate risks, implement effective risk control measures, and maintain a comprehensive Risk Management File (RMF) in compliance with global regulatory requirements such as EU MDR, US FDA regulations, and CDSCO guidelines. It is particularly valuable for professionals in regulatory affairs, quality assurance, design and development, and clinical domains, as it strengthens their ability to ensure product safety, regulatory compliance, and patient protection while supporting market approval and post-market surveillance activities.

This program will enable the participants to:

• Understand the principles and requirements of ISO 14971:2019.
• Identify hazards and hazardous situations associated with medical devices across the product lifecycle.
• Perform risk analysis, evaluation, and risk control using structured methodologies such as FMEA and risk matrices.
• Develop, review, and maintain a comprehensive Risk Management File (RMF).
• Integrate risk management processes with ISO 13485 QMS, design controls, and clinical evaluation requirements.
• Ensure compliance with global regulatory frameworks including EU MDR, US FDA, and CDSCO guidelines.
• Apply post-production monitoring and risk-benefit analysis for continuous safety improvement.

Target Audience

• Regulatory Affairs professionals in the medical device industry
• Quality Assurance (QA) and Quality Control (QC) personnel
• Design and Development engineers
• Risk Management and Compliance officers
• Clinical Affairs and Post-Market Surveillance professionals
• Medical device manufacturers, IVD professionals, and combination product teams
• Consultants involved in CE marking, US FDA submissions, and CDSCO regulatory filings
• Academicians, researchers, and students pursuing careers in medical device regulatory affairs and quality management 

Certified Study Resources

International Affiliation with

Module 1: Introduction to ISO 14971:2019

Module 2: Links to Global Regulatory Requirements (USFDA, EU, CDSCO)

Module 3: Understanding ISO 14971:2019 – Risk Management for Medical Devices: Standard & Implementation

Module 4: General Requirements for a Risk Management System

Module 5: Risk Analysis & Risk Evaluation

Module 6: Evaluation of Overall Residual Risk & Risk Management Review

Module 7: Production & Post-Production Activities

Module 8: Application of ISO 14971:2019, and ISO 13485:2016

Eligibility

Graduates in any discipline are eligible for our Post Graduate Diploma, Executive Diploma and Professional Certification Programmes.

Programme Duration

The duration to complete this programme is 5 days

Programme Mode

Registrations are currently open for regular and Part-time (Online Live Classes) both modes.

Programme Deliverables

The accompanying training is appropriately aligned with the current Industry’s expectations.

• Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
• All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
• Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
• At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
• All learning and training delivery initiatives shall be conducted in English.

Assessment & Certification

All the participants are expected to appear for online assessment. After successfully qualifying the examination, the participants will be awarded Certificate in ISO 14971:2019 Risk Management for Medical Devicesby Faculty of Medical Device, IGMPI.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing placement assistance to its participants. The robust placement cell comprises of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. We are engaged in promoting the employability of our participants by maintaining good rapport and relation with HR cell and recruiting managers of leading food and agriculture companies across the globe. The efforts of our placement cell also include helping with professional resume writing, interview skills & conducting mock interviews etc.

In recent months the Institute has witnessed more and more participation from professionals working with leading multinational and Indian manufacturers contributing to global healthcare innovation. Prominent multinational companies include Medtronic, Abbott, Siemens Healthineers, GE HealthCare, Boston Scientific, and Stryker Corporation, which manufacture a wide range of products including cardiovascular devices, diagnostic imaging systems, orthopedic implants, surgical instruments, and patient monitoring equipment. Alongside them, Indian medical device manufacturers such as Meril Life Sciences, Transasia Bio-Medicals, Poly Medicure, Sahajanand Medical Technologies, and Trivitron Healthcare are rapidly expanding their global presence by manufacturing innovative and affordable medical devices across cardiology, diagnostics, critical care, and interventional segments, thereby strengthening India’s position in the global medical technology market. The IGMPI's Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

Future Prospects

The future prospects of the medical device industry are highly promising, driven by rapid technological advancements, increasing healthcare demands, and supportive regulatory reforms worldwide. Emerging areas such as artificial intelligence–enabled devices, digital health solutions, wearable monitoring systems, robotic surgery, and personalized medical technologies are transforming patient care and expanding global market opportunities. Regulatory frameworks aligned with standards like ISO 14971:2019 and ISO 13485 are further strengthening compliance-driven innovation. In India, initiatives promoting domestic manufacturing and export growth, along with expanding MedTech parks and policy support, are creating strong career and entrepreneurial opportunities in regulatory affairs, quality assurance, clinical research, risk management, and product development. Overall, the sector offers sustained growth, global mobility, and high-impact professional roles focused on patient safety and technological advancement.

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Apply Online

Last date for submitting completed Application Form: 6^th Mar 2026.

For further enquiries, call or write to us on:
18001031071 (Toll Free -9:00 am to 5:30 pm IST-except on Central Government holidays)/ info@igmpi.ac.in