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Executive Diploma in Regulatory Affairs (Medical Device as Major)


Before a medical device can enter any market, it needs to fulfill all the applicable regulatory requirements and gain approval from the concerned regulatory bodies. Regulatory and demographic environment is a part of challenge to medical device industry. The real struggle is to define the strategy, development of appropriate business plan and efficient execution of the same. For that technical expertise is required. All employees should be aware of the expectations and procedures within the company. Assessment of employees is done on the basis of their knowledge and skill.

IGMPI offers an Executive Diploma Programme in Medical Device Regulatory Affairs. The curriculum is designed and developed by experts from the medical device industry and is focused on both theoretical and practical aspects. The Programme is meant for Graduates and Post Graduates, employed plus yet to be employed candidates willing to enter this exciting field of liaison between the technical aspects of a medical device as well as the legal role of submissions and approvals.

Programme Modules :

Module 1: Introduction to Global Regulatory Authorities for Medical Device Industry

Module 2: Medical Devices, In –vitro devices, Biologics & Combination Products: Introductory Module

Module 3: FDA Regulations and Guidelines on Medical Devices

Module 4: European Union Regulatory Guidelines on Medical Devices (Part 1 and Part 2)

Module 5: Medical Device Regulations from Indian perspective

Module 6: Management of the risks associated with Medical devices

Module 7: Biocompatibility Studies and Medical Devices

Module 8: Clinical Trials: Medical Devices

Module 9: Overview of In – Vitro Device Regulation

Module 10: Overview of Combination Products Regulation

Module 11: Medical Device Registration, e-Submissions and Approvals in US, Europe and India

Eligibility

Any graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHMS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

Programme Duration

Minimum time in which a student can complete this diploma programme is 6 months while a maximum of 12 months is allowed to complete the programme.

Registration

The registration dates for this programme run by the Institute are updated timely on the webpage. Effective Online learning tools incorporated into the design of the webpage make the programme lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.

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.

  • – 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 obliged to timely submit completed assessment assignments (during the programme, usually after every module) and appear for an online exam at the end of the programme. After successful completion, the participants will be awarded Executive Diploma in Regulatory Affairs (Medical Device as Major) by Faculty of Medical Device Management, IGMPI. This programme is approved by Quality Council of India (QCI), Government of India. 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 Johnson & Johnson, Novartis AG, Abbott Laboratories, Medtronic PLC, Baxter International, Danaher Corporation, Siemens Healthineers, ResMed Inc., Edwards LifeSciences Corp., GE Healthcare, Philips Healthcare, Alcon Laboratories, Thermo Fisher, Cardinal Health, Medtronic, 3M Company, Stryker Corporation 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 the Training programme in Regulatory Affairs (Medical Device as Major)

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 this particular sector.

Professional and industry oriented training programme such as Medical Device Management by IGMPI, open doors for entry into the industry. Executive Diploma in Quality Assurance and Quality Control (Medical Device as Major) is a fast track 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 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.


Download Prospectus

Programme Fee Details

How to apply

For further enquiries, write to or call us on:
info@igmpi.ac.in / 18001031071 (Toll Free), Phone: +91 11 26512850

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