7.1. Contents of the framework The assessment framework will provide a method for the assessment of software processes in The contents of the framework will include a medical device organisations. The framework will description of the following: include an assessment model that will provide a structured approach for assessment and that may Introduction to the framework; be used by organisations involved in the Intended audience and implementation development, maintenance and support of strategy; software with the following purposes: Software Development Roadmap - a Understanding the of a company’s own suggested step-by-step guide to developing processes for process improvement; software including: Determining the capability of a company’s Life cycle development models and own processes for a particular contract; milestones, Determining the capability of another Roadmap checklists, organisation’s processes for a particular contract. Recommended best practices; Architecture consisting of: The assessment model will include coverage of all An assessment model, associated medical device regulatory standards. The project will take a similar lead in the approach An assessment method, to defining the assessment model based on SPICE Assessment activities; for Space (S4S) in the space sector, and AutomotiveSPICE in the automotive sector that Process assessment and improvement have adapted the ISO/IEC 15504 assessment model concepts to applicable domain standards. Additionally, the outcome will have similarities to the Capability Process improvement, Assessment Tool [10] that was developed by the Process capability determination, Office of Government Commerce, in that it helps an organisation to measure organisational Compliance with medical device capability and to track progression and regulations; achievement in key process areas (with a mapping back to the twelve FDA key areas). 7.2. Software development roadmap The framework will not provide requirements but Of key importance to medical device companies is rather guidelines and recommendations and a model that identifies the major software ensure it endorses the essence of the SPICE and development activities and indicates how they CMMI frameworks.
The assessment framework will provide a method for the assessment of software processes in medical device organisations. The framework will include an assessment model that will provide a structured approach for assessment and that may be used by organisations involved in the development, maintenance and support of software with the following purposes: Understanding the of a company’s own processes for process improvement; Determining the capability of a company’s own processes for a particular contract; Determining the capability of another organisation’s processes for a particular contract. The assessment model will include coverage of all associated medical device regulatory standards. The project will take a similar lead in the approach to defining the assessment model based on SPICE for Space (S4S) in the space sector, and AutomotiveSPICE in the automotive sector that have adapted the ISO/IEC 15504 assessment model to applicable domain standards. Additionally, the outcome will have similarities to the Capability Assessment Tool [10] that was developed by the Office of Government Commerce, in that it helps an organisation to measure organisational capability and to track progression and achievement in key process areas (with a mapping back to the twelve FDA key areas). The framework will not provide requirements but rather guidelines and recommendations and ensure it endorses the essence of the SPICE and CMMI frameworks. 7.1. Contents of the framework The contents of the framework will include a description of the following: Introduction to the framework; Intended audience and implementation strategy; Software Development Roadmap - a suggested step-by-step guide to developing software including: Life cycle development models and milestones, Roadmap checklists, Recommended best practices; Architecture consisting of: An assessment model, An assessment method, Assessment activities; Process assessment and improvement concepts Process improvement, Process capability determination, Compliance with medical device regulations; 7.2. Software development roadmap Of key importance to medical device companies is a model that identifies the major software development activities and indicates how they
A_Software_Process_Development_No.55.docx