{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T05:19:08Z","timestamp":1778044748946,"version":"3.51.4"},"reference-count":19,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,12,10]],"date-time":"2024-12-10T00:00:00Z","timestamp":1733788800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,12,10]],"date-time":"2024-12-10T00:00:00Z","timestamp":1733788800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100005765","name":"Universidade de Lisboa","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100005765","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Health Technol."],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Purpose:<\/jats:title>\n            <jats:p>The primary objective of this study is the preparation of the certification of the Clynx\u00ae Platform, a physiotherapy software, as a Class IIa medical device software in accordance with the regulatory framework outlined in Medical Device Regulation 2017\/745 (MDR).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods:<\/jats:title>\n            <jats:p>The methodology involves a comprehensive analysis of European Union medical device regulations and guidelines, with a specific focus on the certification process essential for obtaining a Conformit\u00e9 Europ\u00e9enne (CE) marking for Class IIa medical device software. This section explores the intricate aspects of the certification process, emphasizing the compilation of Technical Documentation, the nuances of Clinical Evaluation, and the establishment of a Quality Management System. The approach aligns closely with the stipulations of MDR 2017\/745.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results:<\/jats:title>\n            <jats:p>The study includes an industry case study featuring the Clynx\u00ae Platform, developed by Clynx\u00ae Health. Insights derived from the MDR are applied to categorize an in-development version of the software as a Class IIa medical device. The preparation of certification of this product involves the meticulous creation of Intended Use, Classification, General and Safety Performance Requirements, and Clinical Evaluation files, the presentation of an experimental protocol to validate the software\u2019s technical performance for inclusion in the Clinical Evaluation, and a description of an Internal Audit performed on the Quality Management System.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion:<\/jats:title>\n            <jats:p>The certification of Class IIa medical device software necessitates the compilation of thorough Technical Documentation, including an extensive Clinical Evaluation, and the implementation of a robust Quality Management System. The certification process is conducted in collaboration with Notified Bodies, ensuring adherence to the stringent requirements set forth by the regulatory framework.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s12553-024-00914-y","type":"journal-article","created":{"date-parts":[[2024,12,10]],"date-time":"2024-12-10T05:06:53Z","timestamp":1733807213000},"page":"41-52","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Preparing the certification of software as a medical device: a european regulatory analysis and case study on the Clynx\u00aePlatform"],"prefix":"10.1007","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5236-4883","authenticated-orcid":false,"given":"Irina E.","family":"Lopes","sequence":"first","affiliation":[]},{"given":"Joana F.","family":"Pinto","sequence":"additional","affiliation":[]},{"given":"Hugo P.","family":"da Silva","sequence":"additional","affiliation":[]},{"given":"Gon\u00e7alo","family":"Chambel","sequence":"additional","affiliation":[]},{"given":"Carolina","family":"Clemente","sequence":"additional","affiliation":[]},{"given":"Diogo C. F.","family":"Silva","sequence":"additional","affiliation":[]},{"given":"Ant\u00f3nio M.","family":"Montes","sequence":"additional","affiliation":[]},{"given":"Daniela","family":"Sim\u00f5es","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2024,12,10]]},"reference":[{"key":"914_CR1","doi-asserted-by":"publisher","unstructured":"Gelijns AC. Technological Innovation: Comparing Development of Drugs, Devices, and Procedures in Medicine, Background Paper. The National Academies Press, Washington, DC. 1989. https:\/\/doi.org\/10.17226\/9924","DOI":"10.17226\/9924"},{"issue":"1","key":"914_CR2","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1371\/journal.pone.0279697","volume":"18","author":"J Bertram","year":"2023","unstructured":"Bertram J, Kr\u00fcger T, R\u00f6hling HM, et al. Accuracy and repeatability of the Microsoft Azure Kinect for clinical measurement of motor function. PLOS One. 2023;18(1):1\u201315. https:\/\/doi.org\/10.1371\/journal.pone.0279697.","journal-title":"PLOS One"},{"key":"914_CR3","unstructured":"Cheng MY. An overview of medical device policy and regulation. Tech. Rep. 38819, World Bank Group, Washington, D.C. 2007."},{"key":"914_CR4","unstructured":"Clynx\u00ae Health. FRM-TD-01 Classification of the Medical Device. 2023."},{"key":"914_CR5","unstructured":"European Parliament, Council of European Union. Regulation(EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, Regulation (EC) No 178\/2002 and Regulation (EC) No 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC. 2017."},{"key":"914_CR6","doi-asserted-by":"publisher","unstructured":"Giavarina D. Understanding Bland Altman analysis. Biochem Med. 2015;25:141\u201351. https:\/\/doi.org\/10.11613\/BM.2015.015.","DOI":"10.11613\/BM.2015.015"},{"key":"914_CR7","unstructured":"Hirakata VN, Camey SA. An\u00e1lise de Concord\u00e2ncia entre M\u00e9todos de Bland-Altman. Clin Biomed Res. 2010;29(3)."},{"key":"914_CR8","unstructured":"International Organisation for Standardization. ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes. 2016."},{"key":"914_CR9","doi-asserted-by":"publisher","unstructured":"Lopes IE, Adri\u00e3o ML, Clemente P, et\u00a0al. Exploring telerehabilitation with Clynx\u00ae\u00a0Platform: usability and impact assessment. Biomed Biopharm Res 2024;21(1):1\u201323. https:\/\/doi.org\/10.19277\/bbr.21.1.329","DOI":"10.19277\/bbr.21.1.329"},{"key":"914_CR10","doi-asserted-by":"publisher","first-page":"15","DOI":"10.2478\/v10078-012-0075-8","volume":"35","author":"J Sinclair","year":"2012","unstructured":"Sinclair J, Taylor PJ, Greenhalgh A, et al. The test-retest reliability of anatomical co-ordinate axes definition for the quantification of lower extremity kinematics during running. J Hum Kinet. 2012;35:15\u201325. https:\/\/doi.org\/10.2478\/v10078-012-0075-8.","journal-title":"J. Hum. Kinet."},{"key":"914_CR11","unstructured":"Medical Device Coordination Group. MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017\/745 \u2013 MDR and Regulation (EU) 2017\/746 \u2013 IVDR. 2019."},{"key":"914_CR12","unstructured":"Medical Device Coordination Group. MDCG 2020-1 Guidance on Clinical Evaluation (MDR)\/ Performance Evaluation (IVDR) of Medical Device Software. 2020."},{"key":"914_CR13","unstructured":"Medical Device Coordination Group. MDCG 2021-24: Guidance on classification of medical devices. 2021."},{"key":"914_CR14","unstructured":"Medical Device Coordination Group. MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to regulation (EU) 2017\/745 (MDR). 2022."},{"key":"914_CR15","doi-asserted-by":"crossref","unstructured":"Ghorbani N, Black MJ. SOMA: Solving Optical Marker-Based MoCap Automatically. Clin. Orthop. Relat. Res. 2021. arXiv:2110.04431","DOI":"10.1109\/ICCV48922.2021.01093"},{"key":"914_CR16","unstructured":"International Strandardization Organization. ISO 14971:2019 Medical devices \u2014 Application of risk management to medical devices. International Organisation for Standardization: Tech. rep; 2019."},{"key":"914_CR17","unstructured":"International Strandardization Organization. ISO\/TR 24971:2020 - Medical devices - Guidance on the application of ISO 14971. International Organisation for Standardization: Tech. rep; 2020."},{"key":"914_CR18","unstructured":"Correlation and regression. In: T D V Swinscow (ed) Statistics at Square One, 9th edn. BMJ Publishing Group (1997)"},{"key":"914_CR19","unstructured":"World Health Organization. Medical devices: managing the mismatch: an outcome of the priority medical devices project. World Health Organization. 2010."}],"container-title":["Health and Technology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12553-024-00914-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s12553-024-00914-y\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12553-024-00914-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,1,25]],"date-time":"2025-01-25T04:35:07Z","timestamp":1737779707000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s12553-024-00914-y"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12,10]]},"references-count":19,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2025,1]]}},"alternative-id":["914"],"URL":"https:\/\/doi.org\/10.1007\/s12553-024-00914-y","relation":{},"ISSN":["2190-7188","2190-7196"],"issn-type":[{"value":"2190-7188","type":"print"},{"value":"2190-7196","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,12,10]]},"assertion":[{"value":"12 December 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 November 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"10 December 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Irina E. Lopes, Gon\u00e7alo Chambel and Joana Pinto are employed by Clynxio, Lda.. Carolina Clemente is an intern at Clynxio, Lda..","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest\/Competing interests"}},{"value":"The experimental protocol presented on Section  was approved by the Ethics Committee of Escola Superior de Sa\u00fade de Santa Maria with the reference 17\/CES\/2022.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}