Our PLM framework integrates engineering, supply chain, and quality functions to proactively manage product evolution, regulatory changes, and component availability.

Our Services Include:

• Sustaining Engineering – continuous improvement and optimization of existing designs.
• Change Management – controlled updates to materials, components, or processes under full quality oversight.
• Verification of Revisions – testing and documentation to validate design or process changes.
• Quality and Compliance Audits – maintaining adherence to ISO and FDA requirements across the lifecycle.
• Global Support – UK and US teams providing regional supply continuity and technical assistance.

A reliable supply chain is essential to sustaining quality and delivery performance. G&H maintains robust relationships with approved suppliers and integrates risk monitoring into every project to ensure long-term stability.

Our Supply Chain Approach Includes:

• Approved Vendor Qualification – evaluation and onboarding under ISO 13485-compliant systems.
• Material Traceability – lot-level documentation to ensure full regulatory compliance.
• Inventory and Demand Planning – forecasting and stocking strategies aligned with customer demand.
• Supplier Performance Tracking – quality, cost, and on-time delivery metrics continuously reviewed.
• Dual Sourcing Options – mitigation strategies to prevent production disruption.

By combining global reach with local control, we deliver a responsive and resilient supply chain for regulated industries.

Component obsolescence poses real risks to medical devices with long market lives. Our proactive obsolescence management program identifies, evaluates, and mitigates these risks early - protecting device continuity and compliance.

Our Process Includes:

• Component Lifecycle Monitoring – tracking material, supplier, and technology changes.
• Risk Assessment and Replacement Planning – identifying alternatives or redesigns before supply ends.
• Change Control and Validation – ensuring replacements meet all form, fit, and functional requirements.
• Regulatory Documentation – maintaining updated records to support MDR, IVDR, or FDA compliance.

Our engineering and quality teams work together to minimise disruption and maintain product integrity, even as technologies evolve or materials are phased out.

• End-to-end lifecycle ownership - from development to sustainment.
• Integrated supply chain and engineering functions for faster, informed decisions.
• ISO 13485 and FDA 21 CFR 820 compliant processes across all sites.
• Decades of experience supporting regulated, high-complexity product lines.
• Global infrastructure enabling continuity across UK and US manufacturing locations.

Sustaining Confidence Beyond Launch

With G&H managing your product’s lifecycle, you gain a partner dedicated to maintaining quality, availability, and compliance long after your device enters the market.

Partner with G&H for complete lifecycle management - from supply chain oversight to obsolescence mitigation.