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Certified Medical Device Regulatory Affairs Professional

Medical device industry is one of the rapidly growing industries in healthcare, driven by innovation and new technologies. The last few years have seen an unprecedented growth in innovative and improved technologies, which has led to the development of state-of-the-art medical devices and catalyzed growth and advancement in the healthcare industry.

Before a drug or 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 the pharmaceutical and the medical device industry. The real struggle is to define the strategy, development of appropriate business plan and efficient execution of the same. IGMPI offers this certified course to understand the regulatory scenario for Medical Devices.

The curriculum is designed and developed by experts from the medical device regulatory industry and is focused on both theoretical and practical aspects. This course gives maximum coverage of the foundations of the medical devices regulations and their application in the medical device market today and near future.

This certification is also beneficial for professionals from different streams to help them intensify their knowledge. This is an advanced certification having rigorous case studies based methodology throughout the duration.


1. Introduction to Global Regulatory Authorities for Pharma and healthcare industries.
2. Medical Devices, In –vitro devices, Biologics & Combination Products: Introductory Module.
3. Medical Device Regulatory Affairs (International perspective, USA) Part 1.
4. Medical Device Regulatory Affairs (International perspective, USA) Part 2.
5. Medical Device Regulatory Affairs (International perspective, EU) Part 1.
6. Medical Device Regulatory Affairs (International perspective, EU) Part 2.
7. Medical Device Regulatory Affairs (Indian perspective).
8. Medical Device Registration, e-Submissions and Approvals in US, Europe and India.

Eligibility

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

Registration

The registration dates for this bi-annual executive programme run by the Institute are updated timely on the webpage. Effective E-learning tools incorporated into the design of the webpage make the course 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.

  • – 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.

Certification and Membership Fees

Rs. 25,000/- for Indian nationals and 800 USD for overseas Professionals. This covers the certification registration fee and examination fee. An additional membership fee of Rs 4500/-( USD 125 for overseas) is to be paid in order to avail the services of Certified Study Resources and training for the preparation of the certification exam.

Assessment & Certification

All the participants are expected to appear for online assessment. After successful completion the participants will be Certified Medical Device Regulatory Affairs Professional by IGMPI. For all the above mentioned elaborate study resources, Assessment test papers and case studies would be provided by the Institute from time to time. Details get updated on the webpage as well. The certification will be awarded after the required levels of knowledge, skills, professionalism and attitude are assessed through the IGMPI assessment process

Re- Examination

In case the participant is not able to pass the certification exam in first attempt/exam notification, he/she will have to re- register for the next scheduled examination by submitting re- registration form along with the re- registration fee of Rs. 1500/-(50 USD). However, the participants will be given sufficient flexibility in scheduling their “First” certification exam.

Placement Assistance & Corporate Relations

IGMPI offers placement assistance to its students. The Institute has partnered with many organizations for providing placement assistance to its participants. Besides, it has a robust placement cell comprising senior level Human Resources professionals and Talent Acquisition experts which maintain close links with business industry. This cell is continuously engaged in promoting employability of our participants. The efforts of our placement cell also include helping with professional resume writing while also assisting them to polish their interview & soft skills.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare , Medical Devices and food giants like Dr. Reddy’s Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, Ipca Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Biocon , Hindustan Syringes & Medical Devices, Wipro GE Healthcare, Medtronic, Bausch & Lomb, Baxter, Sushrut Surgicals, Wipro Technologies, HCL Technologies etc.


Download Prospectus

Programme Fee Details

How to apply

For further enquiries, write to or call us on::
info@igmpiindia.org/ 011 45768446, +91 8130924488, 8587838177, 8130749005, 8448963304

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