I believe that medical devices act as a tool for treating or diagnosing a patient and hence, it may play a bigger role than doctors themselves in some instances. While doctors, nurses and other medical staff are held to a rigorous performance standard, It is the responsibility of Medical device manufacturers to meet the highest standard of quality for their products. When a person is complaining about quality, he/she is definitely cutting corners. He/she certainly is not following practices that support consistent quality manufacturing nor is he/she aligning with regulatory, enforcement, compliance approaches with those practices.