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
Any Life Science graduate/ B.Pharm/M pharm/MSc/ any diploma holder or passed outs of Clinical Research degree or diploma courses are eligible for these course. Working professionals of any of the following industry types Drugs manufacturing, Medical Device, Ayurveda, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurveda Medicine Manufacturing, Cosmetic Manufacturing, Biotechnology or any related industry are highly encouraged to apply for the programme.
The candidate is expected to complete the course in 3 months.
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.
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).
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.
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 Technologiesetc.
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.
Mr Vinod Arora, Principal Advisor, IGMPI
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like