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Device End-of-Life Management and Obsolescence

Colleagues at ITL, Two men sit side by side at a desk in a bright, modern office, both smiling and looking at a computer screen. The man on the left, with curly red hair and glasses, wears a light blue shirt. The man on the right, wearing a black G&H polo shirt and glasses, holds a 3D-printed part. The background shows a tidy workspace with light wooden furniture and an open office layout

Protecting Product Availability and Compliance

Medical devices and analytical instruments often have lifespans measured in decades - but their components don’t. At G&H, our Obsolescence Management program ensures long-term product continuity by anticipatingand mitigating the risks associated with material or component phase-out.

We continuously monitor component lifecycles, maintain supply alternatives, and coordinate controlled change management - protecting product availability and regulatory compliance.

Proactive Lifecycle Management

Our engineering and supply teams collaborate to identify potential risks early - before they disrupt production or compromise certification.

Our Process Includes:

  • Component Lifecycle Tracking – continuous monitoring of parts, materials, and supplier notices.
  • Risk Assessment and Prioritization – classifying components by criticality, availability, and lead time.
  • Alternative Sourcing and Redesign – qualifying substitute parts or re-engineering designs to maintain form, fit, and function.
  • Change Control and Validation – structured documentation and verification under ISO 13485 and FDA design control requirements.
  • Customer Notification and Approvals – transparent communication of impacts, timelines, and mitigation plans.

Quality and Regulatory Confidence

All obsolescence actions are documented within our Quality Management System, ensuring traceability and compliance with ISO 13485, MDR, IVDR, and FDA 21 CFR 820. Our engineering and quality teams validateany replacement parts or design changes to maintain regulatory equivalence and device performance.

We also assist customers with documentation updates, risk analyses, and verification testing to support global requalification or CE marking continuity.

Why Partner with G&H?

  • Early identification of component risks to prevent production disruption.
  • Integrated engineering and supply chain teams managing redesigns efficiently.
  • Full change-control documentation for regulatory submissions.
  • Proven record supporting long-lifecycle medical and analytical devices.
  • Transparent communication and proactive planning at every stage.

Future-Proofing Your Device

With G&H managing obsolescence, you gain long-term confidence that your product will remain manufacturable, compliant, and available - no matter how technology or supply chains evolve.

Partner with G&H to protect your product’s future and maintain compliance across its lifecycle.

Contact our Lifecycle Management Team