Software System Architecture Development in a Regulated Environment
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Artificial Intelligence in Health Care: the Hope, the Hype, the Promise, the Peril
Artificial Intelligence in Health Care: The Hope, the Hype, the Promise, the Peril Michael Matheny, Sonoo Thadaney Israni, Mahnoor Ahmed, and Danielle Whicher, Editors WASHINGTON, DC NAM.EDU PREPUBLICATION COPY - Uncorrected Proofs NATIONAL ACADEMY OF MEDICINE • 500 Fifth Street, NW • WASHINGTON, DC 20001 NOTICE: This publication has undergone peer review according to procedures established by the National Academy of Medicine (NAM). Publication by the NAM worthy of public attention, but does not constitute endorsement of conclusions and recommendationssignifies that it is the by productthe NAM. of The a carefully views presented considered in processthis publication and is a contributionare those of individual contributors and do not represent formal consensus positions of the authors’ organizations; the NAM; or the National Academies of Sciences, Engineering, and Medicine. Library of Congress Cataloging-in-Publication Data to Come Copyright 2019 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. Suggested citation: Matheny, M., S. Thadaney Israni, M. Ahmed, and D. Whicher, Editors. 2019. Artificial Intelligence in Health Care: The Hope, the Hype, the Promise, the Peril. NAM Special Publication. Washington, DC: National Academy of Medicine. PREPUBLICATION COPY - Uncorrected Proofs “Knowing is not enough; we must apply. Willing is not enough; we must do.” --GOETHE PREPUBLICATION COPY - Uncorrected Proofs ABOUT THE NATIONAL ACADEMY OF MEDICINE The National Academy of Medicine is one of three Academies constituting the Nation- al Academies of Sciences, Engineering, and Medicine (the National Academies). The Na- tional Academies provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. -
Don't Risk It! ISO 13485:2016 and How to Determine Compliance Level
Don’t Risk It! ISO 13485:2016 and How to Determine Compliance Level August 18, 2016 John Beasley, RAC(US) MedTech Review, LLC Thought of the Day: “Act after having made assessments. The one who first knows the measure of far and near wins.” - Sun Tzu, The Art of War 2 Today’s Topics • Overview of changes in ISO 13485, 3rd Edition – Risk management – Usability – Outsourced processes • Supplier evaluation – determining LSP level of compliance • Concluding remarks • Q&A ISO 13485:2016 1 Overview of Changes in the 3rd Edition History of ISO 13485 13485 13485 13485 9001 9001 9001 1994 / 2000 / 2003 2015 / 1996 2008 / 2009 2016 5 Publication History 1996 - Publication of standards ISO 13485 and ISO 13488. • 13485 variant intended for manufacturers responsible for design, manufacture and distribution of devices. • 13488 variant intended for manufacturers not responsible for designing devices. Variants must be used with ISO 9001:1994 and ISO 9002:1994 as applicable. 2003 - Publication of 2nd edition ISO 13485:2003. Considered to be “stand alone”. ISO 13488 now obsolete. Organizations that previously used 13488 must now use 13485 but can exclude section 7.3 “design and development” if allowed by regulations. Device specific requirements that do not apply to the manufacturer are tagged as “not applicable”. 6 Publication History 2004 - Publication of guidance document ISO/TR 14969. Its purpose is to provide a single source of guidance on the interpretation and implementation of 13485. 2009 - Corrigendum to 13485:2003 published to change reference from ISO 9001:2000 to ISO 9001:2008. 2012 - CEN (European standards organization) publishes EN ISO 13485:2012 as the European adoption of ISO 13485:2003 (2009 corrigendum). -
Medical Devices
FRAUNHOFER INSTITUTE FOR EXPERIMENTAL SOFTWARE ENGINEERING IESE MEDICAL DEVICES Contact Fraunhofer Institute for Experimental Software Engineering IESE Ralf Kalmar Software is a part of our lives. Embedded into everyday equipment, into living and working en- [email protected] vironments or modern means of transportation, countless processors and controllers make our Phone: +49 631 6800-1603 lives simpler, safer, and more pleasant. We help organizations to develop software systems that www.iese.fraunhofer.de are dependable in every aspect, and empirically validate the necessary processes, methods, and techniques, emphasizing engineering-style principles such as measurability and transparency. Fraunhofer Institute for The Fraunhofer Institute for Experimental Software Engineering IESE in Kaiserslautern has been Experimental Software one of the world’s leading research institutes in the area of software and systems engineering Engineering IESE for more than 20 years. Its researchers have contributed their expertise in the areas of Process- es, Architecture, Security, Safety, Requirements Engineering, and User Experience in more than Fraunhofer-Platz 1 1,200 projects. 67663 Kaiserslautern Germany Under the leadership of Prof. Peter Liggesmeyer, Fraunhofer IESE is working on innovative topics related to digital ecosystems, such as Industrie 4.0, Big Data, and Cyber-Security. As a technology and innovation partner for the digital transformation in the areas of Autonomous & Cyber-Physical Systems and Digital Services, the institute’s research focuses on the interaction between embedded systems and information systems in digital ecosystems. Fraunhofer IESE is one of 72 institutes and research units of the Fraunhofer-Gesellschaft. To- gether they have a major impact on shaping applied research in Europe and contribute to Ger- many’s competitiveness in international markets. -
ECSO State of the Art Syllabus V1 ABOUT ECSO
STATE OF THE ART SYLLABUS Overview of existing Cybersecurity standards and certification schemes WG1 I Standardisation, certification, labelling and supply chain management JUNE 2017 ECSO State of the Art Syllabus v1 ABOUT ECSO The European Cyber Security Organisation (ECSO) ASBL is a fully self-financed non-for-profit organisation under the Belgian law, established in June 2016. ECSO represents the contractual counterpart to the European Commission for the implementation of the Cyber Security contractual Public-Private Partnership (cPPP). ECSO members include a wide variety of stakeholders across EU Member States, EEA / EFTA Countries and H2020 associated countries, such as large companies, SMEs and Start-ups, research centres, universities, end-users, operators, clusters and association as well as European Member State’s local, regional and national administrations. More information about ECSO and its work can be found at www.ecs-org.eu. Contact For queries in relation to this document, please use [email protected]. For media enquiries about this document, please use [email protected]. Disclaimer The document was intended for reference purposes by ECSO WG1 and was allowed to be distributed outside ECSO. Despite the authors’ best efforts, no guarantee is given that the information in this document is complete and accurate. Readers of this document are encouraged to send any missing information or corrections to the ECSO WG1, please use [email protected]. This document integrates the contributions received from ECSO members until April 2017. Cybersecurity is a very dynamic field. As a result, standards and schemes for assessing Cybersecurity are being developed and updated frequently. -
Regulatory Feasibility Analysis for a New Atrial Fibrillation Ablator in Selected Countries
MQP – FRH – FHO2 Regulatory Feasibility Analysis for a New Atrial Fibrillation Ablator in Selected Countries A Major Qualifying Project Report Submitted to the Faculty of the Worcester Polytechnic Institute in partial fulfillment of the requirements for the Degree of Bachelor of Science in Management by ______________________ Matthew Hammond Approved: _______________________ _______________________ Martin Sklar, President and CEO Frank Hoy, Ph.D. AblaCor Medical Corporation Paul R. Beeswick Professor of Project Sponsor Innovation and Entrepreneurship Project Advisor _______________________ Jerome Schaufeld, Ph.D. Professor of Practice Project Co-Advisor 1 | P a g e Abstract Medical device registration for class three devices, such as a catheter ablator, can be a long and difficult process. The regulatory requirements can vary greatly by country, overlap and benefit one another, or require repeating a certification depending on the country in question. Determining the order in which to enter specific countries greatly depends on the size of the potential market and the costs and time needed for regulatory approval. Prior approval on major facets such as clinical trials may greatly reduce the costs of entering a particular country if the data from an outside source is deemed acceptable. This creates a complex problem where start- ups who cannot afford to pursue regulatory approval in all major markets simultaneously must carefully chose and enter individual markets a few at a time. The paper will evaluate the regulatory pathways of ten select countries. This regulatory analysis, combined with a market analysis on these same countries by the other three members of the project, will form a basis from which we can create a suggested order of entry. -
Risk Management for Manufacturers of in Vitro Diagnostic Medical Devices
Technical Guidance Series (TGS) Risk management for manufacturers of in 1 TGS–07 vitro diagnostic medical devices Draft for comment 25 September 2017 © World Health Organization 2017 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for non-commercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. -
FDARA Section 710 Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices
May 2018 FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices In accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA) Executive Summary The Food and Drug Administration Reauthorization Act (FDARA) became law on August 18, 2017. Section 710 of FDARA charges the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to issue a report on the continued quality, safety, and effectiveness of medical devices with respect to servicing. FDA has considered information including but not limited to the information presented at a public workshop, responses to a request for comments, and evaluation of objective evidence related to the quality, safety, and effectiveness of medical device servicing in the compilation of this report. Stakeholders have differing views about the quality, safety, and effectiveness of servicing performed by original equipment manufacturers (OEMs) and third party entities, and the need for imposing additional regulation. Based on the available information, we have concluded: • The currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third party servicers, of medical devices that would justify imposing additional/different, burdensome regulatory requirements at this time; • Rather, the objective evidence indicates that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices; • A majority of comments, complaints, and adverse event reports alleging that inadequate “servicing” caused or contributed to clinical adverse events and deaths actually pertain to “remanufacturing” and not “servicing”; and • The continued availability of third party entities to service and repair medical devices is critical to the functioning of the U.S. -
Phihong Ev Chargers 2021-2022
2021-2022 PHIHONG EV CHARGERS World Class Quality, International Standards Phihong Technology Co., Ltd is a core member of the organization Charging Interface Initiative e. V. (CharIN e. V.) and member of CHAdeMO Association. The goal is to promote and continuously develop the Combined Charging System (CCS) also ensuring compatibility between the infrastructure and the EVs. PHTV2102E Phihong Technology Phihong is a leading global power products manufacturer with over 50 years of industry experience. As a supplier to many of the world’s leading brands, Phihong continues to design innovative products with an emphasis on envi- ronmental protection and carbon reduction. Phihong offers a complete product line of EV charging OEM/ODM - AC Chargers solutions supporting both commercial and passenger electric vehicles. This includes Level 3 DC chargers ranging from 30kW to 360kW and Level 2 AC EVSE rang- ing from 16 to 48 amps. In addition, Phihong offers DC charging modules, auxiliary power, control & supervisor units (CSU), discrete type DC chargers, integrated type DC chargers, moveable DC chargers, and portable DC chargers. Phihongs EV charging software solutions include a front- OEM/ODM - DC Chargers end mobile APP and user interface (HMI) and a cloud- based management, payment, and monitoring platform. Through the front-end mobile APP, people can search for nearby chargers, schedule charging appointments, and monitor charging status. System operators can monitor the status of individual EV chargers and remotely up- date them, enabling long-term maintenance and man- agement. With strong R&D design capabilities and solid manufacturing experience, Phihong Technology delivers high-quality and cost-effective hardware/software prod- Modules ucts based on specific customer needs. -
Thesis and Dissertation Template
DEVELOPMENT OF A QUALITY MANAGEMENT ASSESSMENT TOOL TO EVALUATE SOFTWARE USING SOFTWARE QUALITY MANAGEMENT BEST PRACTICES Item Type Other Authors Erukulapati, Kishore Publisher Cunningham Memorial library, Terre Haute,Indiana State University Download date 23/09/2021 23:31:43 Link to Item http://hdl.handle.net/10484/12347 DEVELOPMENT OF A QUALITY MANAGEMENT ASSESSMENT TOOL TO EVALUATE SOFTWARE USING SOFTWARE QUALITY MANAGEMENT BEST PRACTICES _______________________ A Dissertation Presented to The College of Graduate and Professional Studies College of Technology Indiana State University Terre Haute, Indiana ______________________ In Partial Fulfillment of the Requirements for the Degree Doctor of Philosophy _______________________ by Kishore Erukulapati December 2017 © Kishore Erukulapati 2017 Keywords: Software Quality, Technology Management, Software Quality Management, Bibliometric techniques, Best Practices VITA Kishore Erukulapati EDUCATION Ph.D. Indiana State University (ISU), Terre Haute, IN. Technology Management, 2017. M.S. California State University (CSU), Dominguez Hills, CA. Quality Assurance, 2011. B.Tech. National Institute of Technology (NIT), Calicut, Kerala, India. Computer Science and Engineering, 1996. INDUSTRIAL EXPERIENCE 2011-Present Hawaii Medical Service Association. Position: Senior IT Consultant. 2008-2010 Telvent. Position: Operations Manager. 2008-2008 ACG Tech Systems. Position: Test Manager. 2000-2008 IBM Global Services. Position: Project Manager. 1996-2000 Tata Consultancy Services. Position: System Analyst. PUBLICATIONS/PRESENTATIONS Erukulapati, K., & Sinn, J. W. (2017). Better Intelligence. Quality Progress, 50 (9), 34-40. Erukulapati, K. (2016). What Can Software Quality Engineering Contribute to Cybersecurity?. Software Quality Professional, 19(1). Erukulapati, K. (2015, Dec 2). Information Technology in Healthcare: Current Status and Future Perspectives. Presented at IEEE Hawaii Chapter - Computer Society Meeting, Honolulu, Hawaii. -
Quality Factors for Mobile Medical Apps
_________________________________________________________________________________________________________________Proceedings of the Central European Conference on Information and Intelligent Systems 229 Quality Factors for Mobile Medical Apps Nadica Hrgarek Lechner Vjeran Strahonja MED-EL Elektromedizinische Geräte GmbH Faculty of Organization and Informatics Fürstenweg 77, 6020 Innsbruck, Austria Pavlinska 2, 42000 Varaždin, Croatia [email protected] [email protected] Abstract. The increased use of mobile phones, less in healthcare. According to a report from the smartphones, tablets, and connected wearable devices business consulting firm Grand Review Research, Inc. has fostered the development of mobile medical (2016), the global connected health and wellness applications (apps) in the last few years. Mobile devices market is expected to reach USD 612.0 billion medical apps are developed to extend or replace some by 2024. existing applications that run on a desktop or laptop The results of the sixth annual study on mobile computer, or on a remote server. health app publishing done by research2guidance If mobile apps are used, for example, to diagnose, (2016) are based on 2,600 plus respondents who mitigate, treat, cure, or prevent human diseases, participated in the online survey. As displayed in Fig. patient safety is at potential risk if the apps do not 1, remote monitoring, diagnostic, and medical function as intended. Therefore, such apps need to be condition management apps are the top three mHealth cleared, approved, or otherwise regulated in order to app types offering the highest market potential in the protect public health. next five years. In 2016, 32% of total respondents There are many papers that have been published predicted remote monitoring apps as the app category about the quality attributes of mobile apps. -
Annual Report 2020 PDF Data
Contents KWE Group Corporate Guidelines (1) We strive to further increase corporate value by delivering 02 Aiming for Sustainable Growth customers quality services that meet their needs and earn their confidence. 06 Foundation for Creating New Value (2) We strive to be an organization that grows and expands through logistics business. 08 Top Message (3) We promote communications with stakeholders and disclose corporate information accurately and 15 Report by Six Segments appropriately. (4) We are committed to comply with external regulations, 21 Sustainability Management and compliance monitoring and assessment are built into all levels of the business. 36 Management’s Discussion and Analysis (5) We ensure a safe and healthy work environment where 43 Financial Highlights people are treated respectfully and fairly. (6) We contribute in sustainable community development, 44 Financial Statements with attention to global environmental issues. 62 Investor Information Guide to Buttons Move Back to Previous Page Expectations and Forecasts This annual report contains statements about our expectations and forecasts regarding plans, strategies, and business results related to the future of Kintetsu World Express, Move Forward to Next Page Inc. (KWE). These statements reflect our expectations based on personal beliefs and assumptions that were determined in light of information that was available at the time Print Search PDF Content the report was prepared. There are innumerable risk factors and uncertainties that could affect the future, including economic trends, competition in the logistics industry, market conditions, fuel prices, exchange rates, and tax or other regulatory system considerations. Go to Contents Page Please be well advised that because of these risk factors, actual results may differ from our expectations. -
Relevant Norms and Standards
Appendix A Relevant norms and standards A.1 A Short Overview of the Most Relevant Process Standards There is a huge number of different process standards, and Fig. A.1 contains an overview of the most relevant such standards as covered in this book, showing the topics covered. A more extensive list of the relevant standards will be provided in the following section below. ISO/IEC 15504, ISO 19011 ISO/IEC 330xx Auditing man- agement systems Process Process assessment ISO/IEC 20000-1 ISO 9001 ISO/IEC 15504-6 ISO/IEC 15504-5 Service management QM system re- System life cycle PAM Software life cycle PAM Assessments, audits Criteria system requirements quirements ISO/IEC/IEEE 15288 ISO/IEC/IEEE 12207 ITIL System life cy- Software life cy- IT Infrastruc- cle processes cle processes ture Library COBIT Life cycle processes SWEBoK Software engineering Funda- Body of Knowledge mentals ISO/IEC/IEEE 24765 ISO 9000 Systems and SW Engineering Vocabulary QM fundamentals (SEVOCAB) and vocabulary Vocabulary Systems Software Organzational IT Quality Management Engineering Engineering Fig. A.1 Overview of the most important standards for software processes © Springer Nature Switzerland AG 2018 327 R. Kneuper, Software Processes and Life Cycle Models, https://doi.org/10.1007/978-3-319-98845-0 328 A Relevant norms and standards A.2 ISO and IEC Standards The International Organization for Standardization (ISO) is the main international standard-setting organisation, working with representatives from many national standard-setting organisations. Standards referring to electrical, electronic and re- lated technologies, including software, are often published jointly with its sister organisation, the International Electrotechnical Commission (IEC), but IEC also publishes a number of standards on their own.