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Certificate in EU Medical Devices Regulation

The Medical Devices Regulation is the legislation detailing the requirements that manufacturers have to meet to place medical devices on the market in the European Union. This course provides essential knowledge to understand Regulatory Affairs of medical devices in EU and also conveys key concepts of the European Medical Devices Regulation. This course focuses on device safety and performance, emphasizing pre-market requirements, conformity assessment, quality management aspects, Post Market Surveillance (PMS), transparency and traceability.


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

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

Module 3 : European Union Regulatory Guidelines on Medical Devices (Part 2)

Module 4 : Medical Device Registration, e-Submissions and Approvals in European Union

Eligibility

Graduation in Pharma/Medical/Biomedical/Biotechnology/Microbiology/Science and Candidates appearing for the final year of Bachelor's degree/equivalent qualification exam or awaiting their results, are eligible to apply.

Programme Duration

The candidate is expected to complete the course in 3 months.

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 recorded lectures on all key areas of the programme giving all flexibility to the participants.
  • 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.

Registration

The registration dates for this 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, videos and study material easily accessible. This gives huge window of self-regulated and self-paced performance to the participants.

Programme Fees

A one-time fees (lump sum paid at beginning of the course) of Rs 10,500 /- (500 USD for oversees students) is mandatory. This covers for the course registration fees, tuition fees, course material fees etc. Apart from this, an examination fee of Rs 450/- (USD 20) per module needs to be paid later as per the examination notification of the Institute. 10% of fee concession is applicable to applicants belonging to SC/ST, Physically Handicapped (PH), Ex- servicemen or those who belong to Economically Weaker Section (EWS)/ Below Poverty Line (BPL).

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 online exam and are also obliged to submit assignments after each module. After successful completion the participants will be awarded Certificate in European Union (EU) Medical Devices Regulation by IGMPI. For all the above mentioned modules elaborate course material, assignment and case studies would be provided by the Institute from time to time. Details get updated on the webpage as well.

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 giants like Dr. Reddy’s Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, 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.

Future career prospects

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. The objective of this course is to impart knowledge and understanding about the medical device regulation legislation procedures that are available and the structure of the registration dossier of medical devices in European Union. Professionals who are willing to have a successful career in medical device industry should attend this course.


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Programme Fee Details

How to apply

For further enquiries, write to or call us on::
info@igmpiindia.org/ +91 8587838177, +91 8130924488, 0120-4375280

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