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The Challenge

OBJECTIVE: GOOD PRODUCTS

Medical device companies seek to place good products in markets around the world in order to provide sound healthcare for patients. They know this means that products—whatever other appealing features they have—should meet certain basic requirements, such as:

  1. They should be designed and manufactured to perform as intended taking account of the state of the art.
  2. They should be manufactured under an established product risk management system.
  3. They should conform to safety principles and risks associated should be reduced.
  4. They should be designed for safety of use in the environment where they will be used.
  5. They should not compromise health or safety of patients or users when used and maintained as ...

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