Prospectus

The Institute of Good Manufacturing Practices India, an autonomous Institute recognised by Ministry of Commerce & Industry, accredited Vocational Institution of Ministry of Education, Government of India and approved by Food Safety and Standards Authority of India (FSSAI), presents a unique, friendly and interactive platform to get rid of all your GMP compliance related issues. GMP—an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing and sustainability services—in itself is the most dynamic part which witnesses frequent changes in terms of new rules being added and old ones being renewed. Thus, keeping oneself updated with current GMPs is essential to remain aligned with evolving industry requirement and standards.

Our team comprises knowledgeable professionals from diverse sectors such as Pharma, Healthcare, Food, Nutraceutical, and Nutrition industries, pooling together their expertise, know-how, and experiences to create this GMP guide. IGMPI is moving hand in hand with technology advances and has gained recognition as a stronger and better education and training platform provider for professionals and students in the areas of GMP, Quality Assurance and Control, Pharma, Food & Nutrition, Environment and Healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR, Good Laboratory Practice and Product Management. Keeping pace with the digital era, IGMPI has also expanded into the domains of Geoinformatics, Remote Sensing, Cybersecurity, Information Security, and Network Security, preparing learners to address the growing need for secure and resilient information systems as well as advanced geospatial solutions.

Our board of governors and specialists have collated their acumen and are offering state-of-the-art courses which include GMP training, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR, Environment Social Governance (ESG), Good Laboratory Practice, Information Security Compliance and Remote Sensing. These are delivered in the form of formal classroom studies, online/interactive programmes, online seminars, and onsite training programmes, along with insights into global industry practices. In short, a round-the-clock service is provided for any information in these areas required by anybody from around the country and abroad.

Based on high standards of quality, the training programmes in Pharma, Healthcare and Food GMP, Quality Assurance and Quality Control, Regulatory Affairs, IPR, Pharma Product Management, Public Health, Hospital Management, Clinical Research, Pharmacovigilance, Medical Writing, Medical Coding, Nanotechnology, Drug Design and Discovery, Food QA&QC have been approved by the Quality Council of India, which is an autonomous body and an accreditation authority for education & vocational training providers under the Ministry of Commerce & Industry, Government of India. IGMPI is duly licensed and certified by Bureau of Indian Standards (BIS) under Bureau of Indian Standards (Conformity Assessment) Regulations 2018.

The Post Graduate and Executive Diploma programmes of IGMPI in Good Manufacturing Practices, Regulatory Affairs, Intellectual Property Rights, Quality Assurance and Quality Control, Public Health, Nanotechnology, Hospital Management, Product Management, Sales and Marketing Management, Clinical Research, Medical Writing, Drug Discovery and Development, Pharmacovigilance, Medical Coding have been duly assessed and approved by Quality Council of India, Government of India based on fulfillment of QCI's following criteria:

    1. Course Content
    2. Course Design
    3. Course Material
    4. Instructors
    5. Class size & Attendance
    6. Facilities
    7. Evaluation of Students
    8. Written Examination
    9. Certificate

IGMPI is also approved by Food Safety and Standards Authority of India (FSSAI) (FSSAI ID: TPINS18). IGMPI® is licensed by Department of Food Safety & Drug Administration under the Drugs and Cosmetics Act, 1940 and registered under Food Safety and Standards Act 2006.

IGMPI is also approved by Sector Skills Council under National Skill Development Corporation (NSDC) setup by Ministry of Skill Development & Entrepreneurship, Govt of India (TC ID:TC342267).

IGMPI has been conferred with the prestigious "BUREAU OF INDIAN STANDARDS (BIS) AWARD OF HONOUR 2023". QUALITY COUNCIL OF INDIA (QCI) has also conferred IGMPI with D.L. SHAH NATIONAL QUALITY AWARD, Certificate of Merit & ASSOCHAM has conferred IGMPI with the Services Excellence Award based on excellence of its services to the students and training participants.

Bureau of Indian Standards (BIS) is a member of International Organization for Standardization (ISO) and through the Indian National Committee (INC) which is a member of International Electrotechnical Commission (IEC). BIS is also a member of regional standards bodies like Pacific Area Standards Congress (PASC) and South Asian Regional Standards Organization (SARSO). India started taking part in IEC from 1911 and subsequently the then Indian Standards Institution (now BIS) took over the responsibility of Indian National Committee of IEC(INC-IEC) in 1949. Since then the INC-IEC is actively participating in the activities of the IEC both at the policy level and technical work and carrying out the responsibilities as member body of IEC Council. India is a member in Standards Management Board (SMB) of IEC since 2015.BIS has also signed Bilateral Cooperation Agreements (BCA)/Mutual Recognition Agreements (MRA) with the National Standards Bodies of several countries like Afghanistan, Bangladesh, Belarus, Egypt, European Union , Germany, Ghana, Greece, Indonesia, Iran, Japan, Jordon, Kenya, Kyrgyzstan, Mali, Mauritius, Nigeria, Russia, Saudi Arabia , Slovakia, Slovenia, Suriname, USA, UAE, Uzbekistan, Viet Nam, Bhutan, Brazil, Israel, Nepal, Pakistan and Sri Lanka.

National Accreditation Board for Certification Bodies (NABCB), Quality Council of India is a member of International Accreditation Forum (IAF) & Pacific Accreditation Cooperation (PAC) as well as signatory to its MLAs for Quality Management Systems, Environmental Management Systems and Product Certification. NABCB is also a Full Member of International Laboratory Accreditation Cooperation (ILAC) & Asia Pacific Laboratory Accreditation Cooperation (APLAC) as well as signatory to its MRAs for Inspection.

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.