NSQF application file- J C 5 - IBSC - AMTZ - Vizag.pdf

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-
  • Code2019/HLT/AMTZ/3579
  • SectorHealthcare
  • NSQF LevelLevel 7
  • Notional Hours500
  • Accrediting BodiesQuality Council of India (QCI)
  • Certifying BodiesIndian Bio Medical Skill Consortium (IBSC)
  • Proposed Occupation

    Project Manager

  • International Comparability

    Association for the Advancement of
    Medical Instrumentation, USA (AAMI) &
    American College of Clinical Engineering
    (ACCE), USA.
    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
    professionals
    http://www.pharmabiz.com/NewsDetails.as
    px?aid=110870&sid=1
    IBSC inks pact with AAMI
    https://www.biospectrumindia.com/news/7
    4/11546/ibsc-inks-pact-with-aami.html

  • Progression Pathway

    Professional Progression
    After the certification, the candidate will
    acquire specialized skills in the field of
    Project Management.
    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.
    Academic Progression
    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
    distance mode.

  • Planned arrangements for RPL

    When the individual has relevant
    experience, he is assessed through a
    Recognition of Prior Learning (RPL)
    programme.
    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
    before assessment.
    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
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