Medical device software definition
Medical device software. Software life cycle processes” [1]. The IEC 62304 has provisions more specific to healthcare use, when compared to more general standards like ISO/IEC 90003 [9] or ISO/IEC 15504 [10]. Also, IEC 62304 is required by some regulatory pathways. The most important step is the actual implementation of the IEC 62304 standard in all aspects of the software development process. Once this implementation is performed, the identification of the specific regulatory pathway will suggest if a formal certification according to this standard is required. If the solution is to be used pre-clinically, it may be possible that no formal certification is required. Still, in most cases the availability of software quality assurance certification is an essential marketing need. A conversation with the prospective customers is indispensable at this stage, to better understand what their expectations in this regard are. If the solution is to be used to support the diagnosis, prognosis or treatment of individual patients then the software is actually a medical device, and to be sold in Europe it needs the CE mark. The regulatory pathway for software as medical device (SaMD) is now well established, and also reasonably harmonised between Europe and USA, so the FDA certification would not impose completely different requirements from the EMA. The recent ASME VV-40 standard [3] provides a step-by-step guideline for the evaluation of the regulatory credibility of predictive software, and we recommend its use, even in Europe where an equivalent harmonised standard does not exist yet. In Europe, the new Medical Device Regulation 2017/745 [11], or MDR, will enter in force in 2021. This poses an additional challenge to start-ups, since there is not yet any experience with the application of this new regulatory framework. For sure, the need of clinical trials for many categories of device, may increase considerably the cost of certification, and might impose the need for some venture capital to support this. The qualification of a computational medicine solution as a new methodology to be used in the assessment of new drugs is the most challenging regulatory pathway (but also the most rewarding commercially). As for the certification under the new MDR the clinical validation is almost unavoidable, and thus the costs of qualification can be important.
Examples of Medical device software in a sentence
MADx reserves the right to make changes and modifications to the Soft- ware at any time, but the software de- velopment will be performed according to the IEC 62304 Standard (Medical device software – software life cycle processes).
MADx reserves the right to make changes and modifications to the Software at any time, but the software development will be performed according to the IEC 62304 Standard (Medical device software – software life cycle processes).