This certification is designed for those working in a Medical Device Industry. 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. It is designed for professionals whose roles and responsibilities require that they understand the basics of Quality control and assurance as well as the points to be held while filing regulatory submissions. This programme gives maximum coverage of the foundations of the medical devices regulations and their application in the medical device market today and near future.
The case study based approach in certification programme is designed for working 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. 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.
Module 1: Introduction to Medical Devices
Module 2: Current Good Manufacturing Practices (India & International)
Module 3: Quality Management Systems and Risk Management to Medical Devices
Module 4: Regulations to Medical Devices (USA, EU and India)
Module 5: Bio compatibility Studies
Module 6: Clinical Trials for Medical Devices
Module 7: Overview of In-vitro Regulation and combination Products
Module 8: Medical Devices and Allied field
The participants must have three years of on-the-job experience in any of related areas. Any graduate/ B.Pharm/M pharm/MSc/Phd in science disciplines/ any diploma /degree holders, 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 as long as they have the required three years of on-the-job experience . Those who have completed their post graduation will need to have 2 years of on-the-job experience and those who have completed their PhD will need to have 1 year of on-the-job experience. Selection will be based on the participant’s profile. IGMPI reserves the right to reject any application with full fee refund.
The registration dates for this certification run by the institute are updated timely on the webpage. Effective Online learning tools incorporated into the design of the webpage make the certification lectures, videos and study resources easily accessible. This gives huge window of self regulated and self-paced performance to the participants. After registration confirmation by the institute, required study resources, assessment test papers will be dispatched to the participants. This study resources is considered sufficient for the preparation of the certification exam. However, the participants should feel free to go through other study resources and resources as well. The certification examination will be notified after 2 months of the registration
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.
All the participants are expected to appear for online assessment. After successful completion the participants will be certified as Medical Device 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.
Membership will be valid for two years and may be renewed by the participant by submitting membership renewal form and membership fee after two years. The Institute reserves the right to conduct an assessment before renewal.
Each participant has to take membership of Institute of Good Manufacturing Practices India (IGMPI) as a part of registration process. All the members will be entitled to receive comprehensive study resources for all the modules along with training guidance in online interactive mode. The membership certificate will also be issued to successful candidates along with their certificate of the professional certification.
In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare like Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Bliss GVS Pharma, SeQuent, Mankind, Beryl Drugs, Allergy Therapeutics, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc. The IGMPI's Corporate Resource Division actively recommends our professionals 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.
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 to ensure design requirements incorporate the defined service strategy/serviceability, participating in design and program reviews to optimize implementation. Certified Medical Device Professional by IGMPI, open doors for entry into the industry 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 as Medical device Quality Assurance Manager, Regulatory Affairs Manager, Quality Assurance Compliance Specialist, Medical Devices Specialist etc.
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like
Moderated by Shri Vinod Arora, Principal Advisor, IGMPI