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AAMI HE74 - HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES
Description: By providing a structured approach to user interface design, this document can help manufacturers develop safe and usable medical devices. This document includes an overview of the human factors engineering (HFE) discipline, a discussion of the benefits of HFE, a review of the HFE process and associated analysis and design techniques, and a discussion of implementation issues and relevant national and international standards and regulations (see annex B).
IEC TR 62366-2 - MEDICAL DEVICES – PART 2: GUIDANCE ON THE APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES - EDITION 1.0
Description: This technical report also can be useful for other healthcare products (e.g. drug packaging and drug LABELLING, drug-MEDICAL DEVICE combination products and health IT software). Purpose The intent of this technical report is to provide guidance related to: • the essential elements of a USABILITY ENGINEERING PROCESS as required by IEC 62366-1:2015, including: – USER research techniques, – analysis techniques, – design techniques, and – MEDICAL DEVICE USABILITY EVALUATION approaches (e.g.
CLSI EP33 - USE OF DELTA CHECKS IN THE MEDICAL LABORATORY - FIRST EDITION
Description: This information may also be of interest to hospital or laboratory informatics staff, and software and medical device vendors who need to understand the laboratory’s goals when implementing automated delta checking.
CRC - BYOD FOR HEALTHCARE - BYOD FOR HEALTHCARE
Description: Thus, we will spend some time in addressing the topics such as content and data management, risk assessment, performance measurement and management, and even configuration management.
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