The rapid advancement of scientific and engineering knowledge in recent years has significantly accelerated the development of innovative medical devices. Combining robust engineering expertise with a deep understanding of medicine and biology is essential for designing devices that are not only effective but also enhance patient outcomes.

Medical devices have become integral to modern healthcare, offering faster and more effective treatment options. They play a vital role in improving the quality of life and longevity for millions across the globe. From deep brain stimulation implants for Parkinson’s disease to knee replacement solutions for osteoarthritis, these innovations showcase the transformative impact of medical technology. Whether it's a basic household device like a thermometer or a sophisticated implant, ensuring the safety and efficacy of these products remains the critical responsibility of regulators.

The introduction of the Medical Devices Rules, 2017, effective from January 1, 2018, marked a significant milestone in the regulatory landscape, creating new avenues for growth and compliance.

In this evolving environment, IGMPI is proud to offer specialised programmes such as the Post Graduate Diploma in Medical Devices Management, meticulously designed to align with industry standards and expectations. For working professionals seeking career advancement, the Executive Diploma in Medical Device Management provides similar benefits, offering flexibility without compromising on quality or relevance.

Together, these programs equip professionals to thrive in the fast-growing and dynamic field of medical devices.

Programme Features:

• Recognised as an autonomous Institute by the Ministry of Commerce & Industry, Government of India.

• Holds both national and international accreditation; detailed information is available on our accreditation page.

• Certified and licensed by the Bureau of Indian Standards (BIS).

• Accredited Vocational Institution under the Ministry of Education, Government of India.

• Approved Training Institute by the Food Safety and Standards Authority of India (FSSAI).

• An Institutional Member of the International Society for Quality in Healthcare (ISQua).

• Certifications offered by IGMPI reflect professional achievement and proficiency, facilitating credentialing.

• Industry-endorsed programmes:

• Post Graduate Diploma: A 12-month comprehensive programme.

• Executive/Industry Diploma: An advanced, fast-track programme of 6 months.

• Faculty comprises highly qualified, professionally competent, and dedicated experts.

• Study materials are comprehensive, dynamic, and aligned with international standards, incorporating case studies for practical understanding.

• A 10% fee concession is available for candidates belonging to SC/ST, physically handicapped individuals, Economically Weaker Sections (EWS), and ex-servicemen for postgraduate diploma courses.

• Classes include practical sessions and online demonstrations scheduled weekly, supported by industry professionals.

• Continuous support is provided to students throughout the programme duration.

• State-of-the-art, accredited laboratory facilities.

• Proactive placement assistance managed by a dedicated placement cell under the supervision of the Director, aimed at nurturing talent.

• Eligibility extends to graduates and candidates in their final year of a Bachelor’s degree or equivalent, including those awaiting results.

This overview underscores our commitment to excellence, industry relevance, and professional development, ensuring our candidates are well-equipped for success.


Module 1: Introduction to Medical Devices

  • Overview of Medical Devices andTheirr Classification (Class A, B, C, D)
  • Medical Device Lifecycle
  • Role in Modern Healthcare
  • Global Market Trends & Key Players

Module 2: Biomedical Engineering Fundamentals

  • Basics of Human Anatomy and Physiology
  • Engineering Principles in Device Design
  • Material Science and Biocompatibility
  • Sterilisation Techniques and Packaging

Module 3: Regulatory Affairs in Medical Devices

  • Indian Medical Device Rules, 2017
  • Central Drugs Standard Control Organisation (CDSCO) Guidelines
  • FDA (US), CE Marking (EU) and ISO 13485
  • Regulatory Submissions, Audits, and Approvals

Module 4: Quality Assurance & Risk Management

  • Quality Management Systems (QMS)
  • ISO 13485 and ISO 14971 Compliance
  • Product Testing and Validation
  • CAPA (Corrective and Preventive Actions) & Risk Analysis

Module 5: Clinical Evaluation and Trials

  • Clinical Evaluation Reports (CERs)
  • Good Clinical Practices (GCP)
  • Post-Market Surveillance (PMS) and Vigilance
  • Adverse Event Reporting

Module 6: Manufacturing and Supply Chain

  • Good Manufacturing Practices (GMP)
  • Process Validation and Documentation
  • Supply Chain Management in Medical Devices
  • Contract Manufacturing and Outsourcing

Module 7: Innovation and Technology in Devices

  • Emerging Technologies: Wearables, AI, IoT, 3D Printing
  • Digital Health & Smart Devices
  • Usability Engineering and Human Factors

Module 8: Business, Marketing & Ethics

  • Market Entry Strategies
  • Pricing and Reimbursement Models
  • Ethics in Device Promotion and Clinical Use
  • Intellectual Property and Patents

Project Work / Dissertation

  • Case Study or Research Project on Device Development, Regulation, or Marketing
  • Guided by Industry Experts or Faculty Mentors

Assessment

  • Module-wise Assignments
  • Online Exams
  • Final Project Evaluation

Career Outcomes

  • Regulatory Affairs Specialist
  • Quality Assurance Manager
  • Clinical Research Associate
  • Product Manager – Medical Devices
  • Compliance Officer
  • Manufacturing/Operations Manager