Case Study

ABC Medical Device Inc. - A Case Study
Consider a Medical Equipment Manufacturing company Medical Equipments Inc.
  • ABC Medical Equipments Inc. is an OEM (Original Equipment Manufacturer), involved in manufacturing innovative medical devices.
  • The manufacture of medical devices face a great challenge to reduce operating costs, and speed up innovative product development.
  • In the rapidly advancing medical field, there is a need to come up with top-edge technology and continuously offer new value-added products. Thus innovation drives the Medical Device OEMs to create precise and accurate instruments with an eye to create new markets for their products.
  • The devices have to undergo exhaustive trials prior to release.
    The medical device manufacturers have a very complicated processes due to strict regulatory methods.
  • ABC Medical Equipments Inc. always strives towards standardization compliance capabilities.
  • The designers involved in manufacturing maintain the Design History Files, Device Master Records and Device History records meticulously.
  • Redesigning is a continuous process and there is a need to maintain an index of all the design numbers and keep the changes tracked.
  • The requirements from the medical fraternity (ABC Medical Equipments’ customers) are always changing and the incidence of ECN (Engineering Change Notices) is very high.
    Also, the after sales service is an essential part of the company’s process.
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