Centre for Pharmaceutical Sciences and Research
Post Graduate Diploma/Executive Diploma in Medical Device Management
www.igmpi.ac.in
About IGMPI

Over the span of years, there has been acceleration in the development of new medical devices due to rapidly expanding scientific and engineering knowledge. Strong engineering skills, supplement with knowledge of medicine and biology helps in the development of better and effective medical devices.

Incorporation of medical devices for treatment endows great benefits to health care system by providing faster and effective treatment options. Medical devices play a critical role in the lives and health of millions of people worldwide. Deep brain stimulation implant for Parkinson’s disease to knee replacing implants for osteoarthritis, these remarkable products lead to increased longevity and improved quality of life. From everyday household product items (e.g. thermometer) to complex implants, responsibility lies on regulators to ensure safety and efficacy.

The U.S. is the largest consumer of medical device market in the world: $156 billion. By 2023, it is likely to grow to $208 billion. The market is likely to grow at a compound annual growth rate (CAGR) of 22.91% during the estimate period from 2021 to 2030. The factors driving the growth of the market include the increasing cost of drug manufacturing, constantly evolving regulations, and growing technology adoption in the pharmaceutical industry.

India is Asia's fourth largest medical device market and one of the top 20 worldwide. The market for medical devices in India is expected to grow at a 35.4% compound annual growth rate (CAGR), with the overall market valued at $12 billion in 2021-22 and $50 billion by 2025. Imports, on the other hand, currently supply the bulk of the country's medical device market, accounting for 80% of overall sales. The major players in the Indian market are Hindustan Syringes & Medical Devices, Opto Circuits (India), Wipro GE Healthcare, 3M India, Medtronic, Johnson & Johnson, Novartis AG, Becton- Dickinson and Company, Abbott, Bausch & Lomb, Baxter, Zimmer Biomet India, Edwards Lifesciences, St. Jude Medical, Stryker, Boston Scientific, BPL Healthcare, Trivitron Healthcare, Accurex Biomedical, Biopore Surgicals etc.

The high reliance on imports presents an appealing opportunity for domestic manufacturers. The 2017 Medical Devices Rules came into effect on January 1 2018, making it the most significant year in terms of regulatory changes for medical device companies. It is a matter of pleasure that IGMPI provides an opportunity to move hand in hand with this emerging industry by bestowing programme such as PG Diploma in Medical Devices Management. Structure of this programme has been designed in such a way that all industry expectations are met expediently.

Working professionals can get similar benefits from the Executive Diploma programme in Medical Device Management.

About IGMPI

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, Nutrition industries, pooling together their expertise, know-how, and practical 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 and Good Laboratory Practice and Product Management. Our board of governors and specialists have collated their acumen and are offering state-of-the-art courses which includes GMP training, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR, Environment Social Governance (ESG), and Good Laboratory Practice in form of formal classroom studies, online/interactive programmes, online seminars, as well as onsite training programmes along with the knowledge of worldwide affairs of the industry. 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, etc., areas have been approved by 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.

Accreditation and Awards

IGMPI is recognized by the Ministry of Commerce & Industry, Government of India and duly licensed and certified by Bureau of Indian Standards (BIS) under Bureau of Indian Standards (Conformity Assessment) Regulations 2018 (License number: ERO/EOMSM/L-8000027) for offering education and training programmes, services and processes in the areas of Pharmaceutical, Food, Nutrition, Healthcare, Environment Health & Safety (EHS), Environmental Social & Governance (ESG) and Marketing Communications.

ministry-of-ci Bureau of Indian Standards

IGMPI is an accredited Vocational Institution of the Ministry of Education, Government of India Institute of Good Manufacturing Practices India is Management System (QMS) certified under NABCB accreditation. IGMPI is also approved by Food and Life Sciences Sector Skill Councils recognized by the National Council of Vocational Education and Training (NCVET).

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.

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.

IGMPI's Membership with IPA

IGMPI is a Lifetime Institutional member of Indian Pharmaceutical Association (IPA).

Indian Pharmaceutical Association (IPA)

Bureau of Indian Standards (BIS)

Bureau of Indian Standards (BIS) came into existence through an act of Parliament in 1987. BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. The Bureau is a Body consisting of 25 members representing both Central and State governments, Members of Parliament, industry, scientific and research institutions, consumer organizations and professional bodies; with Union Minister of Consumer Affairs, Food and Public Distribution as its President and with Minister of State for Consumer Affairs, Food and Public Distribution as its Vice-President.

Quality Council of India (QCI)

Quality Council of India is set up by the Government of India to establish and operate national accreditation structure and promote quality through National Quality Campaign. QCI is registered as a non-profit society with its own Memorandum of Association. QCI is governed by a Council of 38 members and Chairman of QCI is appointed by the Prime Minister on recommendation of the industry to the government. The Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, is the nodal ministry for QCI.

International Recognition

For providing its education and training services to overseas students, IGMPI is registered with the Directorate General of Foreign Trade, Government of India and our Export Import Code is AADCI7680Q.

IGMPI is an Institutional Member of the International Society for Quality in Health Care

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.

IGMPI's Membership with IPA

IGMPI is a Lifetime Institutional member of Indian Pharmaceutical Association (IPA).

IPA

Bureau of Indian Standards (BIS)

Bureau of Indian Standards (BIS) came into existence through an act of Parliament in 1987. BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. The Bureau is a Body consisting of 25 members representing both Central and State governments, Members of Parliament, industry, scientific and research institutions, consumer organizations and professional bodies; with Union Minister of Consumer Affairs, Food and Public Distribution as its President and with Minister of State for Consumer Affairs, Food and Public Distribution as its Vice-President.

Quality Council of India (QCI)

Quality Council of India is set up by the Government of India to establish and operate national accreditation structure and promote quality through National Quality Campaign. QCI is registered as a non-profit society with its own Memorandum of Association. QCI is governed by a Council of 38 members and Chairman of QCI is appointed by the Prime Minister on recommendation of the industry to the government. The Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, is the nodal ministry for QCI.

International Recognition

For providing its education and training services to overseas students, IGMPI is registered with the Directorate General of Foreign Trade, Government of India and our Export Import Code is AADCI7680Q.

IGMPI is an Institutional Member of the International Society for Quality in Health CarelSQua

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.

Post Graduate Diploma/Executive Diploma in Medical Device Management

A medical device includes some of the genuine miracles of modern medicine and offers great challenges. This Industry is knowledge based economy and provides sustainable employment. This can generate exports into rapidly expanding global market.
The Post Graduate Diploma/Executive Diploma Programme offers an opportunity to study in a stimulating environment which includes experience and insights of industry professionals. This programme is offered through online learning modes with the following features:

  • Economic
  • Expedient Access
  • Self paced learning module
  • Flexibility
  • Different learning styles
  • Successful completion

Professionally trained personnel are required to sustain in such challenging environment. IGMPI provides theoretical as well as practical knowledge which provides assurance of sustainability and success in this industry. The programme is meant for all those keen on being a part of Medical Device industry and even working professionals can apply for the programme and affirm a strong position in the industry.

The programme is meant for Graduates and Post Graduates, employed plus yet to be employed candidates keen on taking Medical Devices industry as their career choice.

Programmme Structure

Module 1 : Medical Devices, In –vitro devices, Biologics & Combination Products: Introductory Module

Module 2 : Current Good Manufacturing Practices (International Perspective)

Module 3 : Current Good Manufacturing Practices (Indian Perspective)

Module 4 : Qualification and Validation

Module 5 : Types of Quality Testing (models, types, procedures etc.) in Medical Device

Module 6 : Quality Management System (International Perspective)

Module 7 : Medical Device Regulatory Affairs (International perspective, USA) Part 1

Module 8 : Medical Device Regulatory Affairs (International perspective, USA) Part 2

Module 9 : Medical Device Regulatory Affairs (International perspective, EU) Part 1

Module 10 : Medical Device Regulatory Affairs (International perspective, EU) Part 2

Module 11: Medical Device Regulatory Affairs (Indian perspective)

Module 12: Introduction to Risk Management to Medical Devices

Module 13: Biocompatibility Studies

Module 14: Clinical Trials: Medical Devices

Module 15: Materiovigilance across the Globe

Module 16: Overview of In – Vitro Device Regulation

Module 17: Overview of Combination Products Regulation

Module 18: Artificial Intelligence in Medical Devices

Module 19: Medical Devices and allied fields: Emerging Area

Eligibility

Graduate in any discipline is eligible for our Post Graduate Diploma and Certificate Programmes. For Executive Diploma programmes and Professional Certifications, you need to have at least 1 year of work experience.

Programme Duration

12 months for the Post Graduate Diploma and 6 months for the Executive Diploma.

Programme Mode

Registrations are currently open for regular and online both modes.

Programme Deliverables

A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

  • Assignments for all the programme modules for continuous evaluation and guidance.
  • Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
  • Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
  • 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.

Examination & Certification

IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.

All the participants are expected to appear for an online exam and are also obliged to submit assignments after each module. After successful completion, the participants will be awarded Post Graduate Diploma/Executive Diploma in Medical Device Management by Faculty of Medical Device Management, IGMPI. For all the above-mentioned modules, Online Classes (Online mode) or face-to-face classes (Regular mode), elaborate programme material, self-assessment assignments would be provided by the Institute. Details get updated on the webpage as well.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical like Abbott Laboratories, Medtronic PLC, Baxter International, Danaher Corporation, General Electric, 3M Company, Siemens Healthineers, Stryker Corporation, ResMed Inc., Cardinal Health Inc., Fonar Corporation, Invacare Corporation, Luminex Corp., Mesa Laboratories Inc., Nevro Corp., Smith & Nephew PLC, etc. 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 career prospects of Training in Medical Device Management

Medical Devices Industry is highly alluring sector now a days. Hence, there is fierce competition in this sector. Proper training and knowledge in this field is required so as to reach the pinnacle of success in particular sector.

Professional and industry oriented training programmes such as Medical Device Management by IGMPI, open doors for entry into the industry. Post Graduate Diploma/Executive Diploma in Medical Device Management is a broad spectrum programme which endows theoretical as well as practical knowledge to the candidate required to sustain successfully in industry. After the completion of this programme the candidate gets selected in Associate medical manager, clinical medical manager, clinical operations manager, therapy development specialist, territory manager sales, product manager & industry/sector of his/her interest. This programme is also beneficial for working professionals to gain hike in their sector by getting updated knowledge of the field.

Programme Fee Details
S.No. Programmes Duration Mode Programmes Fee
1 Executive Diploma 6 months Online Rs.85,000/- (USD 1400)
2 Post Graduate Diploma 12 months Online Rs.110,000/- (USD 1500)
3 Post Graduate Diploma 12 months Regular Rs.150,000/- (USD 4000)
Advisory Board and team

Our Advisory Board Members : https://igmpi.ac.in/our-advisors-and-team

Centre for Pharmaceutical Sciences and Research

C-6, Qutab Institutional Area, Near Old JNU Campus, New Delhi–110016, India.
18001031071 (Toll Free -9:00 am to 5:30 pm IST-except on Central Government holidays)/ info@igmpi.ac.in