IBM® ELM for Medical Devices
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.
IBM Engineering benefits for Medical Devices
Reduce time to innovation
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.
Reduce cost of compliance
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.
Improve quality
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.
Embrace agility
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.
Collaborate seamlessly
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.
Produce high-quality products that meet rigorous standards
Today’s electronics and their software environments are evolving at an increasingly rapid pace. Nowhere is that more evident than with advanced medical devices that touch our lives when we are most vulnerable. IBM Engineering Lifecycle Management makes it easier for companies to help support the requirements of the rigorous medical device standards — like ISO 14971, IEC 60812, IEC 62304, IEC 82304-1, ISO 13485, ISO 60601, EU MDR, FDA Title 21 CFR and more — by addressing the joint challenge of managing simultaneous system and software development.
Medical devices resources
Manage compliance for medical devices with IBM
Learn how IBM Engineering Lifecycle Management can help you reach compliance goals through integration, collaboration and automation.
IBM Engineering Lifecycle Management Software Portfolio
The IBM Engineering Lifecycle Management portfolio can help companies transform to a systems approach for developing smart products.
IDC POV: ELM for intelligent medical device manufacturing
Analyst IDC discusses the use of ELM for smarter production of medical devices.