IBM® ELM for Safe, Compliant Medical Devices

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.

Use Cases in Medical Devices

Diagnostic Equipment
Wearables & Implantables
Surgical Instruments
Patient Monitoring Systems

End-to-End Traceability

Built-in Regulatory Compliance

Link requirements, design, test cases, code, and defects across all engineering domains to maintain end-to-end traceability and reduce risk.

Built-in Regulatory Compliance

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.

Integrated Risk Management

Built-in Regulatory Compliance

Integrated Risk Management

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.

Quality-Driven Engineering

Integrated Risk Management

Ensure product quality with integrated testing, verification, and validation. Track test results against requirements to ensure every product is safe, reliable, and compliant.

Collaboration Across Teams

Quality-Driven Engineering

Collaboration Across Teams

Enhance collaboration between global teams, suppliers, and contractors, ensuring consistent version control, real-time updates, and efficient communication across the project lifecycle.

IBM® ELM for Safe, Compliant Medical Devices

Use Cases in Medical Devices

End-to-End Traceability

Built-in Regulatory Compliance

Built-in Regulatory Compliance

Built-in Regulatory Compliance

Built-in Regulatory Compliance

Built-in Regulatory Compliance

Integrated Risk Management

Built-in Regulatory Compliance

Integrated Risk Management

Quality-Driven Engineering

Quality-Driven Engineering

Integrated Risk Management

Collaboration Across Teams

Quality-Driven Engineering

Collaboration Across Teams

Applying Systems Engineering to Healthcare & Medical Devices

For more information and to request a demo, contact us below

IBM® ELM for Safe, Compliant Medical Devices

Use Cases in Medical Devices

End-to-End Traceability

Built-in Regulatory Compliance

Built-in Regulatory Compliance

Built-in Regulatory Compliance

Built-in Regulatory Compliance

Built-in Regulatory Compliance

Integrated Risk Management

Built-in Regulatory Compliance

Integrated Risk Management

Quality-Driven Engineering

Quality-Driven Engineering

Integrated Risk Management

Collaboration Across Teams

Quality-Driven Engineering

Collaboration Across Teams

Applying Systems Engineering to Healthcare & Medical Devices

For more information and to request a demo, contact us below

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