In the medical device industry, innovation must go hand in hand with rigorous regulatory compliance, safety standards, and quality management. From initial concept to market launch - and through ongoing maintenance - managing complex medical devices requires precise coordination, full traceability, and absolute accuracy. Any mistake can affect patient safety and result in costly delays.
IBM® Engineering Lifecycle Management (ELM) provides a comprehensive platform to help medical device manufacturers meet the complex demands of their development lifecycle. Whether you’re designing diagnostic equipment, wearables, surgical devices, or implantables, IBM® ELM ensures full traceability, regulatory compliance, and product quality throughout every stage of the process.
Link requirements, design, test cases, code, and defects across all engineering domains to maintain end-to-end traceability and reduce risk.
Align your development process with global standards such as FDA 21 CFR Part 820, ISO 13485, IEC 62304, and MDR through automated workflows, traceability, and audit-ready documentation.
Manage risk across the lifecycle, from initial design through testing and manufacturing. Identify, assess, and mitigate potential hazards to ensure patient safety and regulatory compliance.
Ensure product quality with integrated testing, verification, and validation. Track test results against requirements to ensure every product is safe, reliable, and compliant.
Enhance collaboration between global teams, suppliers, and contractors, ensuring consistent version control, real-time updates, and efficient communication across the project lifecycle.
Applying Systems Engineering to Healthcare & Medical Devices