figure 1) that addresses the specific software development requirements from relevant regulatory The major process improvement frameworks that bodies, standards, customer expectations, and currently exist, namely ISO/IEC15004 (SPICE) and integrates those constraints with a SPI framework. CMMI, do not address regulatory requirements of The proposed SPI framework will be based on the medical device industry. The US Food and Drug identifiable and relevant components of existing SPI Administration (FDA) and the European Medical models, such as ISO/IEC15504 (SPICE) and CMMI [5]. Device Directives (MDD) are the regulatory The model will be flexible in that relevant elements standards that control the design, development, of the SPI framework may be adopted as required to manufacturing and support of products within the provide the most significant benefit to the business. medical device industry. 5. Project Outline In order to deliver an endorsed framework it was acceptance and implementation within each essential that a steering group was formed with company. members from various medical device companies and a notified body with experience in auditing medical device companies. The involvement of The software development model will cover the medical device companies also adds an ownership complete lifecycle, defined by default, as the element to the model and should improve its in Figure 2. No restriction will be made on the applicable standards and regulations are adhered to development life cycle processes undertaken by in a seamless manner and are focused upon individual companies, although it is understood that software process improvement. companies within the medical device sector typically implement this V-Model. The model will be expanded to incorporate applicable aspects of The framework will also ensure that developed, software improvement programs such as reused or off-the-shelf [6] software satisfies ISO/IEC15504 (SPICE) in addition to checking that all functional, operational and regulatory requirements
figure 1) that addresses the specific software development requirements from relevant regulatory bodies, standards, customer expectations, and integrates those constraints with a SPI framework. The proposed SPI framework will be based on identifiable and relevant components of existing SPI models, such as ISO/IEC15504 (SPICE) and CMMI [5]. The model will be flexible in that relevant elements of the SPI framework may be adopted as required to provide the most significant benefit to the business. The major process improvement frameworks that currently exist, namely ISO/IEC15004 (SPICE) and CMMI, do not address regulatory requirements of the medical device industry. The US Food and Drug Administration (FDA) and the European Medical Device Directives (MDD) are the regulatory standards that control the design, development, manufacturing and support of products within the medical device industry. 5. Project Outline In order to deliver an endorsed framework it was essential that a steering group was formed with members from various medical device companies and a notified body with experience in auditing medical device companies. The involvement of medical device companies also adds an ownership element to the model and should improve its acceptance and implementation within each company. The software development model will cover the complete lifecycle, defined by default, as the in Figure 2. No restriction will be made on the development life cycle processes undertaken by individual companies, although it is understood that companies within the medical device sector typically implement this V-Model. The model will be expanded to incorporate applicable aspects of software improvement programs such as ISO/IEC15504 (SPICE) in addition to checking that all applicable standards and regulations are adhered to in a seamless manner and are focused upon software process improvement. The framework will also ensure that developed, reused or off-the-shelf [6] software satisfies functional, operational and regulatory requirements
A_Software_Process_Development_No.55.docx