Today’s software and systems engineering teams face staggering pressure to develop safety-critical medical technology products and get them to market faster than ever before. Medical device development of these complex products in an optimal manner, requires end-to-end visibility across the entire product engineering lifecycle. IBM Engineering Lifecycle Management (ELM) provides you the ideal management environment for thriving in this safety-critical and competitive product development environment.
Boost transparency and traceability across the development process and better understand how changes can cascade and impact the entire system under development.
Reduce time to market with strategic reuse-leveraging variants. Model systems and software early in the process, reducing more expensive rework late in process. Share data across distributed teams.
Streamline compliance with industry standards ISO 13485, ISO 14971, and IEC 62304; and FDA (21 CFR Part 11, 21 CFR 820) and MDR regulations. Manage development through customizable reporting.
Boost transparency and traceability across the development process. Manage requirement hierarchies and better understand how changes can cascade and impact the entire system under development.
Boost development team productivity by adopting agility at scale, such as using SAFe or your own processes. Use dashboards to see current work status, ownership and trace requirements.
Facilitate team collaboration, manage code, run standups, plan sprints and track work to reduce rework. Get essential software version control, workspace management and parallel development support.