The Experts below are selected from a list of 394464 Experts worldwide ranked by ideXlab platform
Ajit Ashok Shenvi - One of the best experts on this subject based on the ideXlab platform.
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ISEC - Navigating the maze: journey towards an optimal process framework for regulated medical software
Proceedings of the 7th India Software Engineering Conference on - ISEC '14, 2014Co-Authors: Ajit Ashok ShenviAbstract:Medical software development poses an interesting challenge from the process and Quality Management System (QMS) perspective. Being software, on one hand there are several process models/frameworks available in the industry practice, all claiming to be the ultimate pinnacle and this list gets supplemented as more research happens in the area of software engineering. On the other hand, healthcare is a regulated industry governed by region specific regulations. These regulations are not standardized across the globe which makes it quite challenging for a medical device manufacturer to abide by the corresponding country specific regulations where the product is going to be launched. For e.g. US is regulated by Quality Systems requirements of FDA and 510(k) approval process, Europe is governed by CE marking and ISO 13485 standard, China has its SFDA requirements whereas Japan follows PAL regulations. With the software content in the medical device increasing and number of recalls/field issues in medical products being traced to software, the regulators are becoming increasingly stricter when it comes to processes that govern design and development of medical software. Although there are many similarities in all these standards/models as the genesis of all of them is the PDCA (Plan-Do-Check-Act) approach, there are subtle important differences as well because each is optimized for a certain purpose. If regulatory standards are more focused on product safety and risk management, the CMMI® is more oriented towards continuous improvements. There is also lot of utility in the techniques proposed by the Agile and the Six-Sigma methodologies but then by itself these cannot become the complete Quality System. The situation is further aggravated by the fact that every stakeholder has different expectation from the software project teams for e.g. a project manager may want to follow iterative strategy to manage project risks better but the regulators on the other hand may expect documentation/evidences in a water-fall like manner, the top management may expect the team to adhere to all possible standards/models whereas the project team would want to follow as minimum requirements as possible and so on. This paper has tried to depict the challenges and dilemmas faced by medical software development teams because of availability of various models/standards/frameworks and the corresponding pros and cons of each. To navigate through this maze, it starts first by looking at the process landscape with the purpose of these various models/standards, and then tries to analyze the comparISOns that have been done amongst the various models/standards in a number of published technical papers. Based on the experience of using some of these, the paper presents the insight in the form of propositions and recommends QMS architecture -- both structural and operational that can be used by any medical software teams. The QMS based on the proposed structure has led to effort savings, stood the test of time in satisfying majority of the stakeholder needs and simultaneously not compromised on the regulatory aspects. The positive trends on the various performance indicators stand a testimony to the successful implementation of an optimal process framework for regulated medical software.
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Medical software: A regulatory process framework
2010 3rd India Software Engineering Conference ISEC'10 February 25 2010 - February 27 2010, 2010Co-Authors: Ajit Ashok ShenviAbstract:Healthcare industry is governed by regulations which are region or country specific. Since it deals directly with human lives, if a medical device, be it standalone or a connected system or a Healthcare informatics package, is to be launched in a particular country/region, it has to abide by the corresponding medical regulations. However these regulations are not standardized across the globe and that makes it challenging for a medical device manufacturer to abide by the corresponding country specific regulations where the product is going to be launched. For e.g. US is regulated by Quality Systems requirements of FDA and 510 K approval, Europe is governed by CE marking and ISO 13485 standard, China has its SFDA requirements whereas Japan follows PAL regulations. Software is at the heart of all these medical equipments. More and more of the medical devices and the corresponding clinical applications and workflows are now controlled by software. Right from capturing the images generated by the scanner to the processing of these images and subsequent post processing for clinical decision making is done by software. The Picture Archival and Communication system (PACS) system which is the backbone of healthcare Informatics in hospitals has software at its core. So automatically all the software that is written for these products comes under the purview of these medical regulations. Infact the Global Harmonization Task force specifically includes "software" in its definition of medical devices. Software development in many organizations is governed by "software engineering principles" applied through a SEI-CMMI model which lays strong emphasis on establishing sound process framework to ensure a good software quality. So on one hand we have a CMMI based Quality system and on other hand the development and maintenance of "medical software" has to abide by the regulatory structure posed by FDA, ISO 13485 etc. This raises certain fundamental questions for organizations dealing with development and maintenance of "medical software" - Are these Quality systems requirements too diverse or is there any overlap? How much exactly is this overlap? Is it possible to marry both these worlds of CMMI and the regulatory standards and have a common process framework for the organization? If there is an already existing CMMI based system then is it possible to extend it to include the ISO and FDA aspects? And if yes how can this be done? As the medical software industry matures, more and more standards will get added to the regulatory requirement - in such a scenario, how does one keep the scalability and integrity of the Quality system? and other similar questions?. This paper is an attempt to answer these questions by sharing the experience of deploying ISO 13485 and FDA CFR 820 elements in an existing CMMI based Quality Management System for development and maintenance of medical software. It begins by painting the regulatory landscape across the globe - America, Europe, Asia, goes onto explaining briefly the structure of ISO 13485, and FDA Quality systems requirements and summarizes the approach followed by Philips-Healthcare Bangalore centre to achieve the ISO certification in a CMMI based process framework. The paper finally details out a granular mapping of the ISO 13485 clauses to the CMMI Process areas including Generic and Specific practices. This will help any CMMI based organization dealing with medical software to easily map and extend their existing practices to the required regulatory standards and achieve the corresponding certification. Copyright 2010 ACM.
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ISEC - Medical software: a regulatory process framework
Proceedings of the 3rd India software engineering conference on India software engineering conference - ISEC '10, 2010Co-Authors: Ajit Ashok ShenviAbstract:Healthcare industry is governed by regulations which are region or country specific. Since it deals directly with human lives, if a medical device, be it standalone or a connected system or a Healthcare informatics package, is to be launched in a particular country/region, it has to abide by the corresponding medical regulations. However these regulations are not standardized across the globe and that makes it challenging for a medical device manufacturer to abide by the corresponding country specific regulations where the product is going to be launched. For e.g. US is regulated by Quality Systems requirements of FDA and 510 K approval, Europe is governed by CE marking and ISO 13485 standard, China has its SFDA requirements whereas Japan follows PAL regulations. Software is at the heart of all these medical equipments. More and more of the medical devices and the corresponding clinical applications and workflows are now controlled by software. Right from capturing the images generated by the scanner to the processing of these images and subsequent post processing for clinical decision making is done by software. The Picture Archival and Communication system (PACS) system which is the backbone of healthcare Informatics in hospitals has software at its core. So automatically all the software that is written for these products comes under the purview of these medical regulations. Infact the Global Harmonization Task force specifically includes "software" in its definition of medical devices. Software development in many organizations is governed by "software engineering principles" applied through a SEI-CMMI model which lays strong emphasis on establishing sound process framework to ensure a good software quality. So on one hand we have a CMMI based Quality system and on other hand the development and maintenance of "medical software" has to abide by the regulatory structure posed by FDA, ISO 13485 etc. This raises certain fundamental questions for organizations dealing with development and maintenance of "medical software" -- Are these Quality systems requirements too diverse or is there any overlap? How much exactly is this overlap? Is it possible to marry both these worlds of CMMI and the regulatory standards and have a common process framework for the organization? If there is an already existing CMMI based system then is it possible to extend it to include the ISO and FDA aspects? And if yes how can this be done? As the medical software industry matures, more and more standards will get added to the regulatory requirement -- in such a scenario, how does one keep the scalability and integrity of the Quality system? and other similar questions?. This paper is an attempt to answer these questions by sharing the experience of deploying ISO 13485 and FDA CFR 820 elements in an existing CMMI based Quality Management System for development and maintenance of medical software. It begins by painting the regulatory landscape across the globe -- America, Europe, Asia, goes onto explaining briefly the structure of ISO 13485, and FDA Quality systems requirements and summarizes the approach followed by Philips-Healthcare Bangalore centre to achieve the ISO certification in a CMMI based process framework. The paper finally details out a granular mapping of the ISO 13485 clauses to the CMMI Process areas including Generic and Specific practices. This will help any CMMI based organization dealing with medical software to easily map and extend their existing practices to the required regulatory standards and achieve the corresponding certification.
Alice Ravizza - One of the best experts on this subject based on the ideXlab platform.
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Comprehensive Review on Current and Future Regulatory Requirements on Wearable Sensors in Preclinical and Clinical Testing
Frontiers in bioengineering and biotechnology, 2019Co-Authors: Alice Ravizza, Licia Di Pietro, Federico Sternini, Carmelo De Maria, Alberto Audenino, Cristina BignardiAbstract:Medical devices are designed, tested, and placed on the market in a highly regulated environment. Wearable sensors are crucial components of various medical devices: design and validation of wearable sensors, if managed according to international standards, can foster innovation while respecting regulatory requirements. The purpose of this paper is to review the upcoming European Union (EU) Medical Device Regulations 2017/745 and 2017/746, the current and future International Electrotechnical Commission (IEC) and International Organization for Standardization (ISO) standards that set methods for design and validation of medical devices, with a focus on wearable sensors. Risk classification according to the regulation is described. The international standards IEC 62304, IEC 60601, ISO 14971, and ISO 13485 are reviewed to define regulatory restrictions during design, pre-clinical validation and clinical validation of devices that include wearable sensors as crucial components. This paper is not about any specific innovation but it is a toolbox for interpreting current and future regulatory restrictions; an integrated method for design planning, validation and clinical testing is proposed. Application of this method to design wearable sensors should be evaluated in the future in order to assess its potentially positive impact to fostering innovation and to ensure timely development.
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the ubora e infrastructure for open source innovation in medical technology
15th Mediterranean Conference on Medical and Biological Engineering and Computing MEDICON 2019; Coimbra; Portugal; 26 September 2019 through 28 Septem, 2019Co-Authors: Carmelo De Maria, Alice Ravizza, Licia Di Pietro, Andres Diaz Lantada, Mannan Mridha, Janno Torop, June Madete, Philippa Ngaju Makobore, Arti AhluwaliaAbstract:The development of medical devices with open source and collaborative design methodologies has the potential to increase the access to medical technologies, thanks to a feasible reduction of design, management, maintenance, and repairing costs linked to the open access of device blueprints. UBORA is an e-infrastructure for the co-design of open source medical devices, which promotes the compliance with internationally recognized quality standards and regulations for safety and efficacy of devices, taking the EN ISO 13485:2016 and the EU MDR 2017/745 as inspiration. UBORA guides the user through a systematic design process, from the identification of clinical needs, of risks class and relevant standards for the device, and provides project management tools, including a repository, finalized to the preparation of the pre-production device dossier. The process is supervised by expert mentors, which ensure that safety and efficacy criteria are fulfilled. The UBORA e-infrastructure is in line with the 2030 Agenda for the Sustainable Development Goals, promoting and strengthening the initiatives of an international community of designers, healthcare providers and policy-makers, toward the reduction of inequalities in the access to medical devices.
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Comprehensive Review on Current and Future Regulatory Requirements on Wearable Sensors in Preclinical and Clinical Testing
2019Co-Authors: Alice Ravizza, Licia Di Pietro, Federico Sternini, Carmelo De Maria, Cristina Bignardi, Alberto AudeninoAbstract:Background: medical devices are designed, tested and placed on the market in a highly regulated environment. Wearable sensors are crucial components of various medical devices: design and validation of wearable sensors, if managed according to international standards, can foster innovation while respecting regulatory requirements. Material and methods: the purpose of this paper is to take into consideration the upcoming EU Medical Device Regulation 2017/245 and the current and future IEC and ISO standards that set methods for design and validation of medical devices, with a focus on wearable sensors. Risk classification according to the regulation is described. The international standards IEC 62304, IEC 60601, ISO 14971 and ISO 13485 are reviewed to define regulatory restrictions during design, pre-clinical validation and clinical validation of devices that include wearable sensors as crucial components. Results: current and future regulatory restrictions are described, and an integrated method for design planning, validation and clinical testing is described Discussion: application of this method to design wearable sensors should be evaluated in the future in order to assess its potentially positive impact to fostering innovation and to the time-to-market of the device.
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EMBC - Co-design open-source medical devices: how to minimize the human error using UBORA e-infrastructure *
Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Inte, 2019Co-Authors: Licia Di Pietro, Alice Ravizza, Carmelo De Maria, Arti AhluwaliaAbstract:In the complex context of the medical device industry and healthcare systems, the reduction in cost may increase access to medical technologies moving towards global health equity. This paper is focused on the description of UBORA, an e-infrastructure based on a new concept of biomedical engineering which promotes the open-source approach for co-designing medical devices, fostering innovative ideas, needs-based, low-cost and safe technology. UBORA structures the entire design process using EN ISO 13485:2016, standard related to medical technology for inspiration. As a proof of concept, this paper shows an example of the development of an open source medical device for hand rehabilitation, designed using UBORA. We demonstrate the straightforward pathway to gather information on safety requirements. Finally, we describe a usability test of the e-infrastructure performed during the 4th WHO Global Forum on Medical Devices in India.
Loic Mennrath - One of the best experts on this subject based on the ideXlab platform.
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evolution de l ISO 13485 2016 enjeux et application pratique de mise en conformite d un systeme de management de la qualite
2018Co-Authors: Loic MennrathAbstract:Harmoniser les pratiques industrielles est l’un des principaux challenges dans le secteur du dispositif medical ou les produits et les entreprises sont fortement heterogenes. Dans cette optique, la norme sectorielle ISO 13485 decrit des exigences pour les systemes de management de la qualite applicables a tous les dispositifs medicaux. Au debut de l’annee 2016, une nouvelle version de l’ISO 13485 a ete publiee, avec des exigences revues a la hausse. C’est dans un contexte reglementaire particulier que cette norme prend place : les directives europeennes sont en voie d’etre remplacees par deux nouveaux reglements pour lesquels les exigences sont significativement renforcees afin de garantir la securite, la performance et la tracabilite des produits sur le marche. Cette these a pour objectif de synthetiser les nouvelles exigences decrites dans cette norme ISO 13485 : 2016 avec un regard critique et une evaluation de leurs impacts reels sur les industries de sante. Cette revision de la norme exige notamment d’implementer une approche basee sur les risques pour maitriser les processus et la pertinence du systeme qualite des entreprises. Pour faire face a cet enjeu majeur, la derniere partie de la these apporte des recommandations pratiques pour sa mise en place et des methodologies pour son utilisation effective. Les nouvelles exigences documentaires sont egalement envisagees en detaillant le contenu attendu des nouvelles procedures exigees par la norme.
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Évolution de l’ISO 13485 : 2016 : enjeux et application pratique de mise en conformité d’un système de management de la qualité
2018Co-Authors: Loic MennrathAbstract:Harmoniser les pratiques industrielles est l’un des principaux challenges dans le secteur du dispositif médical où les produits et les entreprises sont fortement hétérogènes. Dans cette optique, la norme sectorielle ISO 13485 décrit des exigences pour les systèmes de management de la qualité applicables à tous les dispositifs médicaux. Au début de l’année 2016, une nouvelle version de l’ISO 13485 a été publiée, avec des exigences revues à la hausse. C’est dans un contexte réglementaire particulier que cette norme prend place : les directives européennes sont en voie d’être remplacées par deux nouveaux règlements pour lesquels les exigences sont significativement renforcées afin de garantir la sécurité, la performance et la traçabilité des produits sur le marché. Cette thèse a pour objectif de synthétiser les nouvelles exigences décrites dans cette norme ISO 13485 : 2016 avec un regard critique et une évaluation de leurs impacts réels sur les industries de santé. Cette révision de la norme exige notamment d’implémenter une approche basée sur les risques pour maîtriser les processus et la pertinence du système qualité des entreprises. Pour faire face à cet enjeu majeur, la dernière partie de la thèse apporte des recommandations pratiques pour sa mise en place et des méthodologies pour son utilisation effective. Les nouvelles exigences documentaires sont également envisagées en détaillant le contenu attendu des nouvelles procédures exigées par la norme.
Antonio Coronato - One of the best experts on this subject based on the ideXlab platform.
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Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification
2018Co-Authors: Antonio CoronatoAbstract:No longer confined to medical devices, medical software has become a pervasive technology giving healthcare operators access to clinical information stored in electronic health records and clinical decision support systems, supporting robot-assisted telesurgery, and providing the technology behind ambient assisted living. These systems and software must be designed, built and maintained according to strict regulations and standards to ensure that they are safe, reliable and secure. Engineering High Quality Medical Software illustrates how to exploit techniques, methodologies, development processes and existing standards to realize high-confidence medical software. After an introductory survey of the topic the book covers global regulations and standards (including EU MDD 93/42/EEC, FDA Title 21 of US CFR, ISO 13485, ISO 14971, IEC 52304, IEEE 1012 and ISO/IEC 29119), verification and validation techniques and techniques, and methodologies and engineering tasks for the development, configuration and maintenance of medical software.
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ISO 13485: medical devices - quality management systems - requirements for regulatory purposes
Engineering High Quality Medical Software: Regulations standards methodologies and tools for certification, 1Co-Authors: Antonio CoronatoAbstract:ISO 13485 (medical devices-quality management systems-requirements for regulatory purposes) is an international standard that presents the requirements for a quality management system specific for the realization of medical devices, including software systems with medical purposes. For the reminder of the chapter, we will refer to ISO 13485:2016, which is the latest available version of the standard.
Carmelo De Maria - One of the best experts on this subject based on the ideXlab platform.
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Comprehensive Review on Current and Future Regulatory Requirements on Wearable Sensors in Preclinical and Clinical Testing
Frontiers in bioengineering and biotechnology, 2019Co-Authors: Alice Ravizza, Licia Di Pietro, Federico Sternini, Carmelo De Maria, Alberto Audenino, Cristina BignardiAbstract:Medical devices are designed, tested, and placed on the market in a highly regulated environment. Wearable sensors are crucial components of various medical devices: design and validation of wearable sensors, if managed according to international standards, can foster innovation while respecting regulatory requirements. The purpose of this paper is to review the upcoming European Union (EU) Medical Device Regulations 2017/745 and 2017/746, the current and future International Electrotechnical Commission (IEC) and International Organization for Standardization (ISO) standards that set methods for design and validation of medical devices, with a focus on wearable sensors. Risk classification according to the regulation is described. The international standards IEC 62304, IEC 60601, ISO 14971, and ISO 13485 are reviewed to define regulatory restrictions during design, pre-clinical validation and clinical validation of devices that include wearable sensors as crucial components. This paper is not about any specific innovation but it is a toolbox for interpreting current and future regulatory restrictions; an integrated method for design planning, validation and clinical testing is proposed. Application of this method to design wearable sensors should be evaluated in the future in order to assess its potentially positive impact to fostering innovation and to ensure timely development.
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the ubora e infrastructure for open source innovation in medical technology
15th Mediterranean Conference on Medical and Biological Engineering and Computing MEDICON 2019; Coimbra; Portugal; 26 September 2019 through 28 Septem, 2019Co-Authors: Carmelo De Maria, Alice Ravizza, Licia Di Pietro, Andres Diaz Lantada, Mannan Mridha, Janno Torop, June Madete, Philippa Ngaju Makobore, Arti AhluwaliaAbstract:The development of medical devices with open source and collaborative design methodologies has the potential to increase the access to medical technologies, thanks to a feasible reduction of design, management, maintenance, and repairing costs linked to the open access of device blueprints. UBORA is an e-infrastructure for the co-design of open source medical devices, which promotes the compliance with internationally recognized quality standards and regulations for safety and efficacy of devices, taking the EN ISO 13485:2016 and the EU MDR 2017/745 as inspiration. UBORA guides the user through a systematic design process, from the identification of clinical needs, of risks class and relevant standards for the device, and provides project management tools, including a repository, finalized to the preparation of the pre-production device dossier. The process is supervised by expert mentors, which ensure that safety and efficacy criteria are fulfilled. The UBORA e-infrastructure is in line with the 2030 Agenda for the Sustainable Development Goals, promoting and strengthening the initiatives of an international community of designers, healthcare providers and policy-makers, toward the reduction of inequalities in the access to medical devices.
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Comprehensive Review on Current and Future Regulatory Requirements on Wearable Sensors in Preclinical and Clinical Testing
2019Co-Authors: Alice Ravizza, Licia Di Pietro, Federico Sternini, Carmelo De Maria, Cristina Bignardi, Alberto AudeninoAbstract:Background: medical devices are designed, tested and placed on the market in a highly regulated environment. Wearable sensors are crucial components of various medical devices: design and validation of wearable sensors, if managed according to international standards, can foster innovation while respecting regulatory requirements. Material and methods: the purpose of this paper is to take into consideration the upcoming EU Medical Device Regulation 2017/245 and the current and future IEC and ISO standards that set methods for design and validation of medical devices, with a focus on wearable sensors. Risk classification according to the regulation is described. The international standards IEC 62304, IEC 60601, ISO 14971 and ISO 13485 are reviewed to define regulatory restrictions during design, pre-clinical validation and clinical validation of devices that include wearable sensors as crucial components. Results: current and future regulatory restrictions are described, and an integrated method for design planning, validation and clinical testing is described Discussion: application of this method to design wearable sensors should be evaluated in the future in order to assess its potentially positive impact to fostering innovation and to the time-to-market of the device.
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EMBC - Co-design open-source medical devices: how to minimize the human error using UBORA e-infrastructure *
Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Inte, 2019Co-Authors: Licia Di Pietro, Alice Ravizza, Carmelo De Maria, Arti AhluwaliaAbstract:In the complex context of the medical device industry and healthcare systems, the reduction in cost may increase access to medical technologies moving towards global health equity. This paper is focused on the description of UBORA, an e-infrastructure based on a new concept of biomedical engineering which promotes the open-source approach for co-designing medical devices, fostering innovative ideas, needs-based, low-cost and safe technology. UBORA structures the entire design process using EN ISO 13485:2016, standard related to medical technology for inspiration. As a proof of concept, this paper shows an example of the development of an open source medical device for hand rehabilitation, designed using UBORA. We demonstrate the straightforward pathway to gather information on safety requirements. Finally, we describe a usability test of the e-infrastructure performed during the 4th WHO Global Forum on Medical Devices in India.
