Launching a new medical device requires more than a great design - it demands a controlled, repeatable process. Our cross-functional engineers manage every phase of the transition, ensuring the product design, documentation, and manufacturing infrastructure are aligned and ready for scale.

Our NPI capabilities include:

• Design Transfer Preparation – translation of design intent into controlled manufacturing documentation and work instructions.
• Process Development & Validation – creation of robust, repeatable processes verified through IQ/OQ/PQ qualification.
• Pre-production Prototype Builds – Beta builds under simulated production conditions to verify assembly methods and testing workflows.
• Tooling & Fixture Development – in-house design of custom jigs, fixtures, and automated test equipment.
• Supplier and Material Readiness – procurement planning, supplier qualification, and material verification for full traceability.
• Risk and Quality Planning – FMEA, control plans, and documentation to meet ISO 13485 and FDA 21 CFR 820 requirements.

By introducing manufacturing disciplines early, our NPI process reduces late-stage redesign and validation delays. We collaborate closely with your design authority - whether internal or third-party - to understand functional requirements, cost targets, and regulatory strategy before ramp-up begins.

This early alignment ensures that once design transfer occurs, all documentation, tooling, and quality controls are in place for seamless scale-up.

Our Production Engineering team serves as the operational bridge between NPI and full manufacturing. They oversee process validation, operator training, andtest fixture, and instruction set meets specification and regulatory standards before volume release.

• Proven experience launching Class I–III medical and IVD devices under ISO 13485.
• Fully integrated NPI-to-manufacture framework within one quality system.
• Dedicated project managers for transparency, milestones, and communication.
• In-house validation, tooling, and test development to shorten ramp-up time.
• Global production sites in the UK and USA for scalable delivery.

From Prototype to Production-Ready

Whether your design originates in-house or externally, G&H provides the structure, expertise, and quality oversight to bring it smoothly into manufacturing - on time, on budget, and fully compliant.

Partner with G&H to accelerate your next product’s journey from concept to commercial success.