A guide to creating an efficient and effective quality system for software medical device organizations.

摘要

Software medical device design and development organizations face a myriad of regulations and quality standards that demand specified compliance objectives to be implemented, documented, and verified within their operational management systems. These organizations are simultaneously faced with their paramount business objective of maximizing profitability by maximizing the yield of sellable product while minimizing the cost of production. The goal of the business should be to align the regulatory and quality requirements with their business objectives and satisfy both with a single operational management system. The narrative of this project examines software design and development activities, risk management, software medical device regulatory requirements, and quality system standards. This project results in a software medical device design and development organization operational management system (or a quality system) outline that integrates all compliance, quality, and operational requirements into a single integrated system.