MDRQ #1711: 5. In eliminating or reducing risks related to use error, the manufacturer shall: - MDR Database - EU 2017/745 (MDR) Public Reference Database

MDRQ #1711

MDRQ #1690: ANNEX I GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

MDRQ #1691: CHAPTER I GENERAL REQUIREMENTS

Added by Anonymous over 6 years ago.

Status:

Released

Priority:

Low

Description

5. In eliminating or reducing risks related to use error, the manufacturer shall:

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	MDRQ #1712: (a) reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and	Released					Actions
	MDRQ #1713: (b) give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users).	Released					Actions