Every device manufactured by G&H is built within a robust and audited Quality Management System (QMS) certified to:

• ISO 13485:2016 – Medical Devices Quality Management
• ISO 9001:2015 – Quality Management Systems
• FDA 21 CFR 820 – Quality System Regulation for Medical Devices

We operate with full compliance to MDR 2017/745 and IVDR 2017/746 requirements, ensuring readiness for both European and U.S. market submissions. This framework guarantees that every process - from materials management to device release - meets the highest international regulatory standards.

Our G&H | ITL Ashford site houses a dedicated 30,000 ft² manufacturing facility designed for flexibility, control, and scalability. Each product line operates in controlled production work-cells, complete with dedicated tooling, fixtures, and validated test setups.

In-house capabilities include:

• Precision assembly lines for medical devices and instrument sub-systems
• Surface-mount technology (SMT) lines for complex PCB integration
• Through-hole soldering and cable harness assembly for hybrid devices
• 3D Automated Optical Inspection (AOI) and flying probe testing for quality assurance
• Cleanroom assembly for consumable products and optical subassemblies
• Dedicated test and inspection stations using Quins imaging systems for PCB verification
• Process validation (IQ/OQ/PQ) and operator training to maintain repeatability

Our engineers oversee every production phase, ensuring compliance, traceability, and performance validation for each manufactured device.

We specialize in both complex electromechanical medical devices and high-volume consumables for the diagnostic and life-science sectors:

• Devices: integrated analytical instruments, optical assemblies, and point-of-care diagnostic systems.
• Consumables: microfluidic cartridges, reagent packs, and disposable plastic components requiring cleanroom assembly and packaging.

Whether producing a single integrated platform or millions of disposable consumables, we apply the same disciplined approach to risk management, validation, and quality assurance.

G&H’s manufacturing network extends beyond Ashford through our low-cost region (LCR) partnerships, enabling cost-effective scaling while maintaining quality and compliance. We support customers through all phases of the manufacturing lifecycle - offering pilot, mid-volume, and full-scale production strategies aligned to cost and demand targets.

This dual-site model allows us to:

• Launch products in the UK under strict regulatory oversight.
• Scale efficiently into LCR manufacturing hubs for high-volume production.
• Maintain central quality control and process ownership at G&H.

The result is a seamless transition from low-volume clinical builds to large-scale, commercial production - without compromising performance or compliance.

Beyond assembly, G&H offers aftersales and lifecycle support including:

• Device installation, commissioning, and field service
• Scheduled maintenance and upgrade programs
• Product repair, rework, and returns handling
• Supply chain continuity and obsolescence management

From the first pilot build to global product release, G&H serves as your full-service manufacturing partner, ensuring every device and consumable meets its technical, commercial, and regulatory goals

• Certified excellence under ISO 13485, ISO 9001, and FDA 21 CFR 820.
• Ashford, UK facility purpose-built for regulated medical device manufacture.
• Full range of manufacturing capabilities including SMT, optical assembly, cleanroom builds, and automated inspection.
• Experience across devices and consumables with proven scalability.
• Low-cost region partnerships supporting high-volume, cost-efficient production.
• Comprehensive lifecycle management from prototype to aftersales support.

Partner with G&H for certified, scalable, and globally supported medical device manufacturing.