Each industry will have different interpretations of the concept of Quality and how to prioritize its tenets within their own field of practice, expertise and work experience. Perhaps the best fundamental principle is the definition of Quality given by the International Organization for Standardization (ISO) as “the degree to which a set of inherent characteristics fulfills requirements where a requirement is a need or expectation.” This look at the Medical Devices sector is one in a series of blogs that provides a quick look at how the concept of Quality applies in different industries.
Quality in the medical device industry touches every stage of the manufacturing process and the organization. Most medical device manufactures have a dedicated Quality Assurance group that ensures compliance with regulations relating to design, manufacture, and records management. The fundamental principle of medical devices is safety for the user, whether that user is the patient or … Read more...
