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AAMI HE74 - HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES Organization: AAMI
Date: 2001-01-01
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).
CEI 62-236 - MEDICAL PLANTAR PRESSURE MEASUREMENT DEVICES (PPMDS): MEASURING PERFORMANCE Organization: CEI
Date: 2015-01-01
Description: NOTE 1 The above technical assessment partly takes into account the appropriateness of the acquisition software associated with the PPMD, since the measured quantities shall be read through it (i.e. data from the PPMD shall be obtained only by means of interfaces delivered by the Manufacturer and Operating Systems declared by the Manufacturer).
SEPT - UL 1998 CHECKLIST - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR ANSI/UL 1998-2004 STANDARD FOR SOFTWARE IN PROGRAMMABLE COMPONENTS - REVISION 1 Organization: SEPT
Date: 2012-01-10
Description: A general software configuration of a microprocessor based programmable component typically includes the operating system or executive software, communication software, micro-controller, input/output hardware, and any generic software libraries, database management or user interface software. The Checklist provides an easy-to-use classification scheme of physical evidence comprised of policies, procedures, plans, records, documents, audits, and reviews.
SEPT - UL 1998 CHECKLIST* - * IN EDITABLE MICROSOFT WORD - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR ANSI/UL 1998-2004 STANDARD FOR SOFTWARE IN PROGRAMMABLE COMPONENTS - REVISION 1; INCLUDES ACCESS TO ADDITIONAL CONTENT Organization: SEPT
Date: 2012-01-10
Description: A general software configuration of a microprocessor based programmable component typically includes the operating system or executive software, communication software, micro-controller, input/output hardware, and any generic software libraries, database management or user interface software. The Checklist provides an easy-to-use classification scheme of physical evidence comprised of policies, procedures, plans, records, documents, audits, and reviews.
CRC - KE23211 - MOBILE POINT-OF-CARE MONITORS AND DIAGNOSTIC DEVICE DESIGN Organization: CRC
Date: 2014-09-12
Description: Efficient mobile systems that allow for vital sign monitoring and disease diagnosis at the point of care can help combat issues such as rising healthcare costs, treatment delays in remote and resource-poor areas, and the global shortage of skilled medical personnel. Covering everything from sensors, systems, and software to integration, usability, and regulatory challenges, Mobile Point-of-Care Monitors and Diagnostic Device Design offers valuable insight into state-of-the-art technologies, research, and methods for designing personal diagnostic and ambulatory healthcare devices.
CRC - E7959 - WHAT EVERY ENGINEER SHOULD KNOW ABOUT DEVELOPING REAL-TIME EMBEDDED PRODUCTS Organization: CRC
Date: 2007-10-24
Description: Developing these real-time embedded products requires an understanding of the interactions between different disciplines, such as circuit design, power, cooling, packaging, software, and human interface. This volume provides the knowledge and insight engineers need to make critical design decisions and offers a clear guide for preparing and developing projects in different markets.

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