Abstract
BackgroundAccording to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes. In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of medical device software. A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture).MethodsThe EN 62304 standard outlines minimum requirements for each stage of the software life-cycle, defines the activities and tasks to be performed and scales documentation and testing according to its criticality. The required processes were established for the pre-existent decision-support software FlashDumpComparator (FDC) used during the quality assurance of treatment-relevant beam parameters. As the EN 62304 standard implicates compliance with the EN ISO 14971 standard on the application of risk management to medical devices, a risk analysis was carried out to identify potential hazards and reduce the associated risks to acceptable levels.ResultsThe EN 62304 standard is difficult to implement without proper tools, thus open-source software was selected and integrated into a dedicated development platform. The control measures yielded by the risk analysis were independently implemented and verified, and a script-based test automation was retrofitted to reduce the associated test effort. After all documents facilitating the traceability of the specified requirements to the corresponding tests and of the control measures to the proof of execution were generated, the FDC was released as an accessory to the HIT facility.ConclusionsThe implementation of the EN 62304 standard was time-consuming, and a learning curve had to be overcome during the first iterations of the associated processes, but many process descriptions and all software tools can be re-utilized in follow-up projects. It has been demonstrated that a standards-compliant development of small and medium-sized medical software can be carried out by a small team with limited resources in a clinical setting. This is of particular relevance as the upcoming revision of the Medical Device Directive is expected to harmonize and tighten the current legal requirements for all European in-house manufacturers.
Highlights
According to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes
As the European state-of-the-art is represented by harmonized standards, this implies the application of the European standard (EN) International organization for standardization (ISO) 13485 standard [3] on quality management systems for medical devices, the EN 62304 standard [4] on medical device software life-cycle processes and the EN ISO 14971 standard [5] on the application of risk management to medical devices together with the International electrotechnical commission (IEC)/Technical report (TR) 80002-1 technical report [6] providing guidance on its application to medical device software (Figure 1)
Risk analysis A rapid prototyped version of the FDC written in C++ was used as the basis for the requirements analysis by an interdisciplinary 6-person team of accelerator physicists, computer scientists, medical physicists and software testers which was subsequently turned into a requirements specification
Summary
According to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of medical device software. The last amendment 2007/47/EC [2] of said directive clarifies the softwarerelated requirements by an extension of the so-called essential requirements laid down in Annex I which are applicable to all medical devices regardless of whether they are placed on the market or not It states that standalone software for diagnostic and/or therapeutic purposes is considered a medical device, and that for medical devices which incorporate or are software, the software must be validated according to the state-of-the-art taking into account the principles of development life-cycle, risk management, validation and verification. Medical software has been written and applied for at least three decades, the first edition of the EN 62304 standard harmonized in 2008 is the first standard dealing with standalone software (before, all software fell within the scope of the EN 60601-1-4 standard [7] on programmable electrical medical systems)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
