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by Prof David Hutchinson and Dr Joris Bannenberg
Clinical Investigation on Medical Devices for Human Subjects (ISO14155:2011) is an international standard that is applied to the conduct of clinical trials on new medical devices. Trial investigators, which includes physicians and other healthcare professionals at all levels of experience, have ISO14155 responsibilities. These requirements are largely unknown by most researchers. Investigators who do not work in accordance with ISO14155 will be unable to perform trials on new medical device products in the future.
ISO14155 helps to protect trial subjects and puts into place systems that encourage reliable data to be collected in the medical device trial. These are important aims for the investigator, the trial sponsor and the authorities that review the results of trials as part of a decision making process.
This easy to read, illustrated, bullet point guide covers the most importantISO14155:2011 responsibilities for the trial investigator and their team doing trials on medical devices. The 12 ‘golden rules’ presented help investigators comply with the globally applicable ISO 14155:2011 requirements.
Also includes best practice advice.