It strengthens links to ISO and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety-related aspects of medical device user interfaces.
Medical equipment are an important tool in efforts to improve patient care and treatment outcomes. As a result, international regulations and standards applicable to medical devices are being continuously revised and updated to reflect potential safety issues that can result from increasingly complex device designs.
While all medical device and in vitro diagnostic IVD manufacturers that claim conformity to ISO should be familiar with the risk management documentation requirements established in this standard, small and medium-sized manufacturers frequently encounter challenges in preparing their risk management files, especially those wishing to market CE marked devices in accordance with the requirements of EN ISO OD Ed 2.
Application of Risk Management to. Medical Devices? Page 1 of 2. Clause Title. Overview of ISO EN ISO Deviations Presumption of? Jun 25, 1. Notified Bodies Recommendation Group. Consensus Paper for the. Interpretation and Application of Annexes Z in. Device Manufacturers. White paper produced by Maetrics. For more information, please contact global sales.
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