{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,12]],"date-time":"2026-04-12T21:00:36Z","timestamp":1776027636160,"version":"3.50.1"},"reference-count":15,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,4,1]],"date-time":"2025-04-01T00:00:00Z","timestamp":1743465600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Digit. Health"],"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>The legislation regarding in-house development of medical devices has changed substantially with the introduction of the Medical Device Regulation (MDR) in 2021. Practical guidelines regarding the implementation of a quality management system for in-house developed medical software are scarce. In this article, we describe our experience with fulfilling the requirements of the MDR for an in-house developed prediction model, qualified as medical software.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and materials<\/jats:title><jats:p>Our quality management system (QMS) is based on the ISO13485:2016. It is a workflow consisting of elements subdivided in subelements, which consist of procedures, work instructions and\/or formats. Within the data science team procedures regarding the process and documentation of software development were already in place. The existing procedures and documentation were compared with the procedures of the QMS and where possible, integrated into the workflow. The gap between the existing procedures regarding software development and the procedures of the QMS was defined. Existing documentation and procedures were used as much as possible. If there was a gap, additional documentation was written.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The majority of the (sub)elements was considered to be applicable for our software development project beforehand. Only in 6 out of 32 cases (19%), the (sub)element was deemed not applicable. For 32% of the applicable elements the documentation of the data scientists team was sufficient and additional information was not needed. For 23% the documentation was incomplete and we decided to add relevant information to fulfil the requirements of the MDR and for 45% the documentation was completely lacking and the standard formats were used.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>We showed in this article that it is possible to use a QMS developed with physical medical products in mind for medical software and thus comply with applicable legislation and regulations. This can be done without too much effort when there is already some structured form of software development methodology in place.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fdgth.2025.1461107","type":"journal-article","created":{"date-parts":[[2025,4,1]],"date-time":"2025-04-01T06:47:04Z","timestamp":1743490024000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":2,"title":["Applying and validating a quality management system for in-house developed medical software"],"prefix":"10.3389","volume":"7","author":[{"given":"Vera","family":"Lagerburg","sequence":"first","affiliation":[]},{"given":"Michelle van den","family":"Boorn","sequence":"additional","affiliation":[]},{"given":"Reinier F.","family":"Crane","sequence":"additional","affiliation":[]},{"given":"Koen","family":"Welvaars","sequence":"additional","affiliation":[]},{"given":"Jaap M.","family":"Groen","sequence":"additional","affiliation":[]}],"member":"1965","published-online":{"date-parts":[[2025,4,1]]},"reference":[{"key":"B1","article-title":"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 (Text with EEA relevance.)","year":"2017"},{"key":"B2","first-page":"1","article-title":"MDCG 2023-1-Guidance on the health institution exception under Article 5(5) of Regulation (EU) 2017\/745 and Regulation (EU) 2017\/746 - January","year":"2023"},{"key":"B3","article-title":"ISO 13485:2016 Medical devices \u2014 Quality management systems \u2014 Requirements for regulatory purposes","year":"2016"},{"key":"B4","article-title":"Council Directive 93\/42\/EEC of 14 June 1993 concerning medical devices","year":"1993"},{"key":"B5","doi-asserted-by":"publisher","first-page":"e163","DOI":"10.1016\/S2589-7500(19)30067-6","article-title":"Challenges in the design and regulatory approval of 3D-printed surgical implants: a two-case series","volume":"1","author":"Willemsen","year":"2019","journal-title":"Lancet Digit Heal"},{"key":"B6","doi-asserted-by":"publisher","first-page":"1","DOI":"10.3390\/jpm12030395","article-title":"Vital role of in-house 3D lab to create unprecedented solutions for challenges in spinal surgery, practical guidelines and clinical case series","volume":"12","author":"Willemsen","year":"2022","journal-title":"J Pers Med"},{"key":"B7","doi-asserted-by":"publisher","first-page":"942588","DOI":"10.3389\/fdgth.2022.942588","article-title":"A perspective on a quality management system for AI\/ML-based clinical decision support in hospital care","volume":"4","author":"Bartels","year":"2022","journal-title":"Front Digit Heal"},{"key":"B8","doi-asserted-by":"crossref","first-page":"2722","DOI":"10.36740\/WLek202012204","article-title":"Artificial intelligence in medical practice: regulative issues and perspectives","volume":"73","author":"Pashkov","year":"2020","journal-title":"Wiad Lek"},{"key":"B9","doi-asserted-by":"publisher","first-page":"432","DOI":"10.1016\/j.semradonc.2022.06.012","article-title":"Regulatory aspects of the use of artificial intelligence medical software","volume":"32","author":"Zanca","year":"2022","journal-title":"Semin Radiat Oncol"},{"key":"B10","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.ejmp.2021.02.011","article-title":"The EU medical device regulation: implications for artificial intelligence-based medical device software in medical physics","volume":"83","author":"Beckers","year":"2021","journal-title":"Phys Medica"},{"key":"B11","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1177\/20552076221089079","article-title":"Will the EU medical device regulation help to improve the safety and performance of medical AI devices?","volume":"8","author":"Niemiec","year":"2022","journal-title":"Digit Heal"},{"key":"B12","article-title":"ISO 14971:2019 Medical devices \u2014 Application of risk management to medical devices","year":"2019"},{"key":"B13","doi-asserted-by":"publisher","first-page":"E1351-7","DOI":"10.1503\/cmaj.202434","article-title":"Implementing machine learning in medicine","volume":"193","author":"Verma","year":"2021","journal-title":"CMAJ"},{"key":"B14","first-page":"29","article-title":"CRISP-DM: towards a standard process model for data mining","author":"Wirth","year":"2000"},{"key":"B15","article-title":"Software Medical Device QMS","year":""}],"container-title":["Frontiers in Digital Health"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fdgth.2025.1461107\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,1]],"date-time":"2025-04-01T06:47:10Z","timestamp":1743490030000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fdgth.2025.1461107\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4,1]]},"references-count":15,"alternative-id":["10.3389\/fdgth.2025.1461107"],"URL":"https:\/\/doi.org\/10.3389\/fdgth.2025.1461107","relation":{},"ISSN":["2673-253X"],"issn-type":[{"value":"2673-253X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4,1]]},"article-number":"1461107"}}