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The Mirage microfiber sirolimus eluting coronary scaffold
Published in Yoshinobu Onuma, Patrick W.J.C. Serruys, Bioresorbable Scaffolds, 2017
Teguh Santoso, Liew Houng Bang, Ricardo Costa, Daniel Chamié, Solomon Su, Alexander Abizaid, Yoshinobu Onuma, Patrick W.J.C. Serruys
Adverse events were reported according to the ISO 14155:2011 Clinical Investigation of Medical Devices For Human Subjects–Good Clinical Practice Guidelines, while recognizing and following other specific laws, regulations, directives, standards, and/or guidelines as appropriate and as required by the countries in which the study was conducted.
Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives
Published in Expert Review of Medical Devices, 2023
Alan G Fraser, Elisabetta Biasin, Bart Bijnens, Nico Bruining, Enrico G Caiani, Koen Cobbaert, Rhodri H Davies, Stephen H Gilbert, Leo Hovestadt, Erik Kamenjasevic, Zuzanna Kwade, Gearóid McGauran, Gearóid O’Connor, Baptiste Vasey, Frank E Rademakers
For general guidance relating to medical devices, the EU regulatory system applies ISO 13485 about quality management systems [93], ISO standard 14,155 which describes the clinical investigation of medical devices [94] (or more correctly their equivalents EN ISO 13485:2016, and EN ISO 14155:2020, but note that only the first of these has been harmonized to the MDR), and ISO 14971 on risk management [95]. ISO 14155 recommends principles for clinical evaluation and mentions types of studies (in Annex I) but it does not prescribe particular methodologies or clinical trials whether for AI systems or any other type of medical device. A new and more specific ISO standard concerning clinical evaluation for medical devices has been proposed, to recommend methodologies for collecting and appraising clinical data across the full lifecycle of a device. If formally adopted, then responsibility for developing and producing the standard within 3 years will be passed to the same working group that prepared ISO 14155 (namely ISO/TC 194 WG4).
Preparing healthcare, academic institutions, and notified bodies for their involvement in the innovation of medical devices under the new European regulation
Published in Expert Review of Medical Devices, 2022
Francesco Garzotto, Rosanna Irene Comoretto, Lorenzo Dorigo, Dario Gregori, Alessandro Zotti, Gaudenzio Meneghesso, Gino Gerosa, Mauro Bonin
To assist stakeholders in applying MDR, a Medical Device Coordination Group has released guidance on clinical investigation and evaluation, the European database on medical devices (EUDAMED), the Unique Device Identifier (UDI), and other relevant issues [36]. The MEDDEV documentation [37], developed under the MDD, was released by the EU Commission to assist stakeholders in implementing directives providing guidance for the evaluation of methodological quality and scientific validity. Among many other standards relevant to the MDR [38], the ISO 14155 addresses good clinical practices for the design, conduction, recording, and reporting of clinical investigations aimed at assessing the effectiveness and safety. Furthermore, to assist European regulators and Member States, NBs as well as manufacturers, an expert panel intended both to support the scientific assessment and to advise on high-risk medical devices of 12 clinical areas, including safety and performance, was established in 2019 [39].
Regulatory convergence of medical devices: a case study using ISO and IEC standards
Published in Expert Review of Medical Devices, 2018
Kuniki Imagawa, Yoshiaki Mizukami, Seiko Miyazaki
ISO is an independent, nongovernmental, international organization with a membership of 162 national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market-relevant international standards that support innovation and provide solutions to global challenges. It consists of 250 Technical Committees (TCs) and defines the scope of each TC [22]. In the medical device industry, for example, ISO/TC 210 ‘Quality management and corresponding general aspects for medical devices’ develops standards such as ISO 13485 ‘Medical devices – Quality management systems – Requirements for regulatory purposes’ and ISO 14971 ‘Medical devices – Application of risk management to medical devices.’ ISO/TC 194 ‘Biological and clinical evaluation of medical devices’ develops standards such as ISO 10993–1 ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’ and ISO 14155 ‘Clinical investigation of medical devices for human subjects – Good clinical practice.’ Further, ISO/TC 106 ‘Dentistry,’ ISO/TC 121 ‘Anesthetic and respiratory equipment,’ etc. develop many standards related to medical devices.