Certificate in Biomedical Project Management
- Job DescriptionThe objective of the training program is to develop a pool of workforce which can be employed by focuses on the acquisition of skills necessary to develop leadership skills as per medical device industry requirement. As per the training modules at the end of the training, the candidate would be certified to perform following activities - a) Quality Planning and Functions Throughout the Product Lifecycle, understand the peculiarities of different regulatory agencies and add greater burdens on new product development. b) The development of Medical Products by following rigid processes to ensure that a high quality, safe, and effective end product is built to meet customer requirements. c) Support in product manufacturing, fabricating component parts, delivering active pharmaceutical ingredients, consulting for clinical trials, regulatory, or project management, supplying product distribution networks, and storing medical data. d) Minimize the length of time from concept to market, number of studies, size and complexity of the clinical trials, and requirements for various countries’ regulatory approvals are staggering. The detail progression is given in the item no 30 of this document.
- Originally Approved23rd NSQC - August 2019
- Last Revised-
- NSQF LevelLevel 7
- Notional Hours500
- Accrediting BodiesQuality Council of India (QCI)
- Certifying BodiesIndian Bio Medical Skill Consortium (IBSC)
- Proposed Occupation
- International Comparability
Association for the Advancement of
Medical Instrumentation, USA (AAMI) &
American College of Clinical Engineering
ACCE is a global leader in Medical
Technology Certification (applicable worldwide).
IBSC has signed MoU with ACCE
for bilateral acceptance of practice.
International documentation reviewed for
the same included that following –
IBSC forges global partnership with AAMI
to certify biomedical engineering
IBSC inks pact with AAMI
- Progression Pathway
After the certification, the candidate will
acquire specialized skills in the field of
Initially the candidate enters the profession
as Executive, with this professional
certificate candidate gets promoted to higher levels as Project Engineer, Project
Manager, Senior Manager, General
Manger, and Head.
For diploma candidates they can entry
directly to second year of engineering
program in Bio-medical. Also, they can
purse degree in distance mode.
For engineering candidates, they can
pursue M. Tech Biomedical or MBA. Also,
they can pursue PG programme in
- Planned arrangements for RPL
When the individual has relevant
experience, he is assessed through a
Recognition of Prior Learning (RPL)
The candidate is assessed through a
combination of theory test, practical
knowledge and verbal questioning or VIVA.
The test is designed by SME or Subject
Matter Expert who prepares the test
material with total integrity and objectivity.
The candidate is administered a written
test of 45 minutes and a practical test of
1.5 to 2 hours duration.
Upon successful completion of the test the
candidate is declared competent for yet to
be competent, depending upon which the
training is advised.
The assessment is conducted by trained
and qualified assessors appointed by
IBSC. The tests are administered under
strict confidentiality and absolute lack of
bias or prejudice.
For those with relevant years of experience
in the medical device industry they can
take direct assessment. In case if
candidate couldn’t qualify, he/she needs to
under-take the training followed by
assessment. However, it is recommended
to the candidates to take required training
For those with less than relevant years of
experience they should undergo training
followed by assessment.
For those with Diploma qualification need 5
years of relevant experience.
For those with Engineering qualification
need 3 years of relevant experience.
- Qualification File NSQF application file- J C 5 - IBSC - AMTZ - Vizag.pdf
- Supporting Documents
- Formal structure of the qualification
Title of unit or other component Estimated size (Hours) Level PM01 Basic concepts & Application of Project Management 100 7 PM02 Project Modelling and Management with Applications in MS – Project 100 7 PM03 People Management in Projects 75 7 PM04 Scope Management 75 7 PM05 Applying Project Management Principles to Biomedical Industry 150 7 Total 500 7
- Formal structure of the qualification