Medical device standards outline the requirements for developing medical devices. These standards however, do not outline how these requirements should be implemented causing difficulties for organisations entering the medical device domain.The goal of this study is to validate a roadmap for the implementation of the ISO 14971 standard. The validation examined the arrangement of the milestones within the roadmap and grouping of the goals into milestones.Five experienced risk management personnel in the medical device domain were asked to complete an on-line questionnaire examining their opinion on the structure and content of the roadmap.Overall participants found the roadmap in general, to be well structured and well organised and made some recommendations for improving the roadmap through merging of specific goals and rearrangement of the milestones within the roadmap.The implementation of a risk management process for the medical device domain can be a costly and time consuming process, however this can be alleviated through the use of a software process improvement roadmap for risk management.

Organizations engaged in medical device software development are required to demonstrate compliance with a set of medical device standards and regulations before the device can be marketed. One such standard IEC 62304, Medical Device Software—Software Life Cycle Processes, defines the processes that are required in order to develop safe software. Demonstrating compliance with IEC 62304 can be problematic for organizations that are new to or have limited experience in the domain. The standard defines what processes must be carried out but does not state how. In a review of a number of such organizations, it was found that the development of a software development plan proved to be a difficult task. In this work we have created a software development plan template to assist organizations with this arduous task. The software development plan template will be validated with these organizations as part of the future work.

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Abstract.One stated objective of the European Union is to encourage SME's expand their area of operation into other domains. The medical device domain is one such domain identified by the EU. Medical device software development must be carried out in a manner that compliance with certain medical device standards and regulations can be demonstrated. IEC 62304, Medical device software -software life cycle processes, is a standard that defines the processes that are required to be executed in order to develop safe software. SME software development organizations wishing to expand their operations into the medical device software development domain face serious challenges in demonstrating compliance with IEC 62304. The standard describes the set of processes, activities, and tasks that are required to be carried out, but importantly do not describe how they should be carried out. This paper describes the development of a roadmap that will aid software development SME's, entering the medical device software development domain, by the use of design patterns to generate "How-to" artefacts, overcome the challenge of demonstrating compliance.

Manufacturers of medical devices must comply with certain legislation and regulations before they can market their products in the European Union (EU). The EU has introduced this legislation and regulation to provide the frameworks by which manufacturers can produce safe and effective medical devices in a consistent manner. The EU has accomplished this by way of Medical Device Directives and harmonised standards. Manufactures, by demonstrating compliance with a harmonised standard, can be presumed to have complied with the essential requirements of the legislation. IEC 62304 Medical device software-Software lifecycle processes is a harmonised standard. However, the standard provides no clear directions for meeting the requirements of the standard. A Software Process Improvement (SPI) Roadmap for IEC 62304:2006 has been developed as a method for aiding medical device software development organizations in implementing the standard. The Roadmap is divided into two levels, the high level consists of the Activities and Tasks necessary for the implementation of the standard, while the low level contains the Design Patterns and How-to artefacts linked to the Tasks. This paper presents the findings from the expert review of the high level roadmap.