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Certificate in EU IVD Medical Device Regulation

IVD devices (In Vitro Diagnostics) are a subset of medical devices primarily used for to testing human fluids such as blood, tissue or urine in a test tube. This may include reagents, instruments and specimen receptacles. In Europe, the In-Vitro Diagnostic Devices Directive (98/79/EC) is used to regulate IVDs. In Vitro Diagnostic (IVD) manufacturers that need to market their devices in Europe need a strategy to successfully navigate through the certification process framed by the 98/79/EC directive governing in vitro diagnostic medical devices. Similar to the Medical Device Directive (MDD), the IVD Directive (IVDD 98/79/EC), includes requirements that govern the device's performance and manufacturing, market placement and demands on safety and quality.

This certificate programme is designed for professionals in full time employment or those who have prior industry experience who want to update their knowledge and gain required skills and attitude in the area in order to become a certified professional in the domain.


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 : EU Directive 98/79/EC

Module 5 : Conformity Assessment Procedures

Eligibility

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.

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 EU IVD Medical Device 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.


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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