S3003
Invited Speaker
ESTRO 2026
In-house development is one of the options to achieve this step towards clinical use. A clear separation should be made between research (software) development and clinical (software) development in order to avoid any bias/limitations and to raise the quality to the clinical level. Considerations before starting any medical device development process, the following should be assessed • Is it a medical device in the first place? • Are there alternative devices on the market? • Is it worth the investment of the required resources? Regulations and norms The process of medical device creation is regulated by the MDR and especially, article 5.5 is of interest to a health institution, posing the requirement for an appropriate QMS. Obviously, when AI is used, the AI- act also needs to be considered. Development should be done using a QMS which is (preferably) based on norms. Our (certified) QMS for software development is based on: • ISO13485: QMS for medical devices • ISO14971: Risk management • IEC62304: Software development QMS A QMS is a set of procedures with accompanying templates and work instructions. The QMS is used to guide the (planned) development process from requirements to release as well as the support/follow- up: • Requirements • Risk management • Development • Testing • Regulatory: GSPR and declaration • Clinical evaluation • Post market surveillance The ISO13485 norm is very general, requiring an implementation which can be tailored to the local habits while still adhering to the norm. The norm can be used to create a QMS for hardware development as well as a QMS for software development. Although different, both can be Added value Working in a QMS for medical device development yields • Well documented and tested clinical grade device • Short time from idea to clinic • Straightforward generation of IMDD for clinical studies • Easier collaboration with industrial partners References: MDR: REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive
established in the EU that meets all conditions set in Article 5(5) of the MDR. The survey consisted of seven sections: (i) responder background; (ii) quality management of in-house software development; (iii) in-house software for research/academic use; (iv) developing in-house software in the clinic; (v) MDR compliance; (vi) respondent's training and preparedness, and (vii) optional open-ended questions on MDR reception/outlook. Results Eighty-one responses were received from 21 European countries. 83% of the respondents declared they had a background in software development, but 43% lacked regulatory experience. 93% of the respondents indicated their specialty as being MPP, contributing to Radiation Oncology (23%), Diagnostic & interventional Radiology (19%) and Nuclear Medicine in (8%). 65% of organisations did not have a Quality Management System (QMS) tailored for in-house software development. For organisations having a QMS and using standards for in-house software development, the most common were ISO13485, ISO14971, and IEC62304. Many organisations did not have dedicated resources for software development and some relied exclusively on ad-hoc testing. In ~50% of the institutions, the development of in- house MDSW was permitted, and in 23% of the cases a specific authorization was required; in just 2% of cases, the development of in-house MDSW was prohibited. The main reason for in-house software development was the cost of commercial alternatives. Principal uses of in-house software were related to the evaluation of image quality and management of machine QA. Conclusion A significant disparity in in-house software development practices (including validation) was observed. Justification for in-house MDSW development, training and resource allocation may need to be reviewed. National initiatives to promote awareness and clarification of MDR requirements would further promote appropriate measures to facilitate the MDR’s clinical integration. 5325 In-house medical device development Alexis Kotte Radiotherapy, UMC Utrecht, Utrecht, Netherlands Introduction Successful research should be brought into the clinic, possibly by the creation of a medical device, to show its real clinical benefit and (thereby) increase patient treatment quality.
Made with FlippingBook - Share PDF online