In the context of the European in vitro medical device, or IVD, market, new Directives and Regulations have been introduced recently, with the intent of improving the traceability of medical devices and associated specifications and management related to the manufacturing process. These included the publication in May 2017 of the IVDR 2017, a regulation valid at European level, which replaces the European Directive 98/79/EC. Beside the substantial difference in the change from Directive to Regulation, among the new features, a new risk classification system for in vitro medical devices has been introduced, particularly for their software. This is no more based only on the assessment of the risks generated in different contexts, but also on the performance of the device, so on the type of analysis performed according to the intended use. Manufacturers had to adapt to the newly introduced regulations, in order to achieve compliance and sell their devices in Europe. Among them, Syes s.r.l., a company where I had the opportunity to do a internship, had to conform its Waver device, an ultrasound IVD able to detect the features of cellular phospholipid membranes, to the new regulations. Its operation is based on software packages, developed for the analysis of different cell types, aimed at recognizing the specific cell line. Among the various documents, which were submitted for obtaining compliance, the software risk analysis of the device had to be updated according to the new regulations. The analysis has been focused on the SW subcomponents, or SW items, related to the performance, so on generation of the ultrasound wave. Moreover, their effect was considered based on their interaction with other SW items in other subcomponents of the system, like FPGA, Baremetal, Android, and Graphic User Interface (GUI), to determine which SW items were involved for each requirement regarding performance, for a complete risk analysis. A software risk assessment document was created, considering performance-related risks, including the type of fault caused by the SW item, the harm generated, the sequence of events leading to harm, the hazard, the risk classification, the risk control measure applied, and the residual risk classification.
Nel contesto del mercato europeo dei dispositivi medici in vitro, o IVD, negli ultimi anni sono state introdotte nuove Direttive e Regolamenti, con l’intento di migliorare la rintracciabilità dei dispositivi medici e delle specifiche ad essi associate e la gestione legata al processo di produzione. Tra queste, è stata pubblicata nel Maggio 2017 l’IVDR 2017, un regolamento valido a livello europeo, che sostituisce la Direttiva Europea 98/79/CE. A parte la differenza sostanziale del passaggio da Direttiva a Regolamento, tra le diverse novità è stato introdotto un nuovo sistema di classificazione del rischio dei dispositivi medici in vitro, in particolare del software. Questa si basa non più solo sulla valutazione dei rischi apportati in diversi contesti, ma anche sulla performance del dispositivo, quindi sul tipo di analisi effettuata in base all’uso previsto. Le aziende fabbricanti hanno dovuto adeguarsi alle nuove disposizioni introdotte per ottenere la conformità e vendere in Europa i propri dispositivi. Tra queste, la Syes s.r.l., società in cui ho avuto l’opportunità di fare un periodo di stage lavorativo, ha dovuto conformare al nuovo Regolamento il proprio dispositivo Waver, un IVD ad ultrasuoni in grado di rilevare le caratteristiche delle membrane fosfolipidiche cellulari. Il suo funzionamento si basa su pacchetti software, sviluppati per l'analisi di diversi tipi di cellule, finalizzati a riconoscere la linea cellulare specifica. Tra i diversi documenti, che sono stati presentati per la ottenere la conformità, si è dovuta aggiornare l’analisi del rischio software del dispositivo in base alle nuove disposizioni. L’analisi si è focalizzata sulle sottocomponenti del software, o software items, legati alla performance del dispositivo, ossia all’erogazione dell’onda ad ultrasuoni. Inoltre, si è considerato il loro effetto in base all’interazione con altri software items di altre sottocomponenti del sistema, ossia FPGA, Baremetal, Android e Graphic User Interface (GUI), per determinare quali fossero, per ciascun requisito riguardo alla performance, i software items coinvolti. Analizzato ciò, si è creato un documento di valutazione dei rischi software, considerando specialmente quelli legati alla performance, comprendente il tipo di malfunzionamento causato dal software item, il pericolo generato, la sequenza di eventi generante il pericolo, il rischio, la classificazione del rischio, la misura di controllo del rischio applicata e la classificazione del rischio residuo.
Software risk analysis of an in vitro medical device with IVDR 746/2017
MANTICA, IRENE
2022/2023
Abstract
In the context of the European in vitro medical device, or IVD, market, new Directives and Regulations have been introduced recently, with the intent of improving the traceability of medical devices and associated specifications and management related to the manufacturing process. These included the publication in May 2017 of the IVDR 2017, a regulation valid at European level, which replaces the European Directive 98/79/EC. Beside the substantial difference in the change from Directive to Regulation, among the new features, a new risk classification system for in vitro medical devices has been introduced, particularly for their software. This is no more based only on the assessment of the risks generated in different contexts, but also on the performance of the device, so on the type of analysis performed according to the intended use. Manufacturers had to adapt to the newly introduced regulations, in order to achieve compliance and sell their devices in Europe. Among them, Syes s.r.l., a company where I had the opportunity to do a internship, had to conform its Waver device, an ultrasound IVD able to detect the features of cellular phospholipid membranes, to the new regulations. Its operation is based on software packages, developed for the analysis of different cell types, aimed at recognizing the specific cell line. Among the various documents, which were submitted for obtaining compliance, the software risk analysis of the device had to be updated according to the new regulations. The analysis has been focused on the SW subcomponents, or SW items, related to the performance, so on generation of the ultrasound wave. Moreover, their effect was considered based on their interaction with other SW items in other subcomponents of the system, like FPGA, Baremetal, Android, and Graphic User Interface (GUI), to determine which SW items were involved for each requirement regarding performance, for a complete risk analysis. A software risk assessment document was created, considering performance-related risks, including the type of fault caused by the SW item, the harm generated, the sequence of events leading to harm, the hazard, the risk classification, the risk control measure applied, and the residual risk classification.| File | Dimensione | Formato | |
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https://hdl.handle.net/10589/216912