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AAMI TIR32 - MEDICAL DEVICE SOFTWARE RISK MANAGEMENT Organization: AAMI
Date: 2004-01-01
Description: The report attempts to clarify process relationships outlined in ANSI/AAMI SW68:2001, Medical device softwareSoftware life cycle processes, and ANSI/AAMI/ISO 14971:2000, Medical devices—Application of risk management to medical devices, in the context of software system safety, keeping in mind the varied interests of the audience.
SAE JA1003 - SOFTWARE RELIABILITY PROGRAM IMPLEMENTATION GUIDE Organization: SAE
Date: 2004-01-01
Description: Four areas of evidence are discussed in terms of benefits and limitations: 1. evidence from software components and structure; 2. evidence from static analysis of the software product; 3. evidence from testing of software under operational conditions; and 4. evidence of process quality.
IEC TR 62366-2 - MEDICAL DEVICES – PART 2: GUIDANCE ON THE APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES - EDITION 1.0 Organization: IEC
Date: 2016-04-01
Description: This technical report discusses the business benefits of USABILITY ENGINEERING, the basics of applicable analysis and design techniques, MEDICAL DEVICE USABILITY EVALUATION approaches, efficient ways to address USABILITY ENGINEERING project implementation issues (e.g. integration into a quality management system) and provides a list of useful USABILITY ENGINEERING resources.
CRC - BIODENTAL ENGINEERING IV - BIODENTAL ENGINEERING IV Organization: CRC
Date: 2017-11-22
Description: The contributions provide a comprehensive coverage of the state-of-the art in this area, and addresses the following topics: • Aesthetics • Bioengineering • Biomaterials • Biomechanical disorders • Biomedical devices • Computational bio- imaging and visualization • Computational methods • Dental medicine • Experimental mechanics • Signal processing and analysis • Implantology • Minimally invasive devices and techniques • Orthodontics • Prosthesis and orthosis • Simulation • Software development • Telemedicine • Tissue engineering • Virtual reality BIODENTAL ENGINEERING IV will be of interest to academics and professionals involved or interested in dentistry, biomechanical disorders, numerical simulation, orthodontics, implantology, aesthetics, dental medicine, medical devices and medical imaging.
SEPT - IEC 62304 CHECKLIST - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR STANDARD IEC 62304:2015 “MEDICAL DEVICE SOFTWARESOFTWARE LIFE CYCLE PROCESSES” - REPLACES PRODUCT 40 Organization: SEPT
Date: 2015-10-20
Description: Clarification of requirements and updates for Software Safety Classification to include a risk-based approach, focus on overall medical device risk analysis.
CRC - KE16151 - SAFETY AND HUMAN ERROR IN ENGINEERING SYSTEMS Organization: CRC
Date: 2012-07-05
Description: The book also covers safety and human error transportation systems, medical systems, and mining equipment as well as robots and software. Nowadays, engineering systems are an important element of the world economy as each year billions of dollars are spent to develop, manufacture, and operate various types of engineering systems around the globe.
SEPT - IEC 62304 CHECKLIST* - * IN EDITABLE MICROSOFT WORD - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR STANDARD IEC 62304:2015 “MEDICAL DEVICE SOFTWARESOFTWARE LIFE CYCLE PROCESSES” - REPLACES PRODUCT 40; INCLUDES ACCESS TO ADDITIONAL CONTENT Organization: SEPT
Date: 2015-10-20
Description: Clarification of requirements and updates for Software Safety Classification to include a risk-based approach, focus on overall medical device risk analysis.
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).
CRC - KE25821 - COMPUTATIONAL VISION AND MEDICAL IMAGE PROCESSING IV : VIPIMAGE 2013 Organization: CRC
Date: 2013-10-01
Description: International contributions from 16 countries provide a comprehensive coverage of the current state-of-the-art in the fields of: 3D Vision; Computational Bioimaging and Visualization; Computational Vision and Image Processing applied to Dental Medicine; Computational Vision; Computer Aided Diagnosis, Surgery, Therapy, and Treatment; Data Interpolation, Registration, Acquisition and Compression; Image Processing and Analysis; Image Segmentation; Imaging of Biological Flows; Medical Imaging; Physics of Medical Imaging; Shape Reconstruction; Signal Processing; Simulation and Modeling; Software Development for Image Processing and Analysis; Telemedicine Systems and their Applications; Trabecular Bone Characterization; Tracking and Analysis of Movement; Virtual Reality.
WILEY - DESIGN AND DEVELOP - DESIGN AND DEVELOPMENT OF MEDICAL ELECTRONIC INSTRUMENTATION: A PRACTICAL PERSPECTIVE OF THE DESIGN CONSTRUCTION AND TEST OF MEDICAL DEVICES Organization: WILEY
Date: 2005-01-01
Description: Master the building blocks of medical devices with this hands-on guide This book provides a uniquely practical approach that enables readers to learn the design of medical electronic devices through the analysis of specific projects. Walking you through the building blocks of implementing medical devices, Design and Development of Medical Electronic Instrumentation addresses the practical aspects of amplifying, processing, simulating, and evoking biopotentials.
CRC - ELEC HLTH REC: SYS ANALY MEDS DOMN - ELECTRONIC HEALTH RECORD: A SYSTEMS ANALYSIS OF THE MEDICATIONS DOMAIN Organization: CRC
Date: 2012-03-22
Description: When applied correctly, systems analysis can accelerate development, decrease costs, and increase the quality of a software product and eventually user satisfaction.
CRC - KE34472 - COMPUTATIONAL VISION AND MEDICAL IMAGE PROCESSING V : PROCEEDINGS OF THE 5TH ECCOMAS THEMATIC CONFERENCE ON COMPUTATIONAL VISION AND MEDICAL IMAGE PROCESSING (VIPIMAGE 2015, TENERIFE, SPAIN, OCTOBER 19-21, 2015) Organization: CRC
Date: 2015-11-18
Description: International contributions from 19 countries provide a comprehensive coverage of the current state-of-the-art in the fields of: 3D Vision; Computational Bio-Imaging and Visualization; Computational Vision; Computer Aided Diagnosis, Surgery, Therapy and Treatment; Data Interpolation, Registration, Acquisition and Compression; Industrial Inspection; Image Enhancement; Image Processing and Analysis; Image Segmentation; Medical Imaging; Medical Rehabilitation; Physics of Medical Imaging; Shape Reconstruction; Signal Processing; Simulation and Modelling; Software Development for Image Processing and Analysis; Telemedicine Systems and their Applications; Tracking and Analysis of Movement and Deformation; Virtual Reality.
CRC - TELEMEDICINE AND ELECTRON - TELEMEDICINE AND ELECTRONIC MEDICINE Organization: CRC
Date: 2015-11-24
Description: This handbook also intends to bridge the gap between scientists, engineers, and medical professionals by creating synergy in the related elds of biomedical engineering, information and communication technologies, network operations, business opportunities, and dynamically evolving modern medical and healthcare practices.
CRC - TELEHEALTH AND MOBILE HEA - TELEHEALTH AND MOBILE HEALTH Organization: CRC
Date: 2015-12-02
Description: This handbook also intends to bridge the gap between scientists, engineers, and medical professionals by creating synergy in the related fields of biomedical engineering, information and communication technologies, network operations, business opportunities, and dynamically evolving modern medical and healthcare practices.
CRC - KE26510 - BRAIDED STRUCTURES AND COMPOSITES : PRODUCTION, PROPERTIES, MECHANICS, AND TECHNICAL APPLICATIONS Organization: CRC
Date: 2015-08-05
Description: Featuring chapters authored by leading experts in their respective fields, this first-of-its-kind book: Explains the basic principles of braiding technology for industrial textiles, composites, and products Identifies the key parameters that influence the braiding process and its produced structures Shows how to control these parameters to achieve the desired material characteristics Discusses braided structure modeling and analysis techniques and software tools Describes various application requirements and their design solutions Braided Structures and Composites: Production, Properties, Mechanics, and Technical Applications supplies a critical understanding of braiding from concept to product design and application.
CRC - DEVELOPING A POLY-CHRONIC - DEVELOPING A POLY-CHRONIC CARE NETWORK: AN ENGINEERED, COMMUNITY-WIDE APPROACH TO DISEASE MANAGEMENT Organization: CRC
Date: 2012-10-29
Description: He'd seen a presentation by another management engineer who'd used a simulation software package called Arena to replicate the flow of a patient through the entire hospital.

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