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Medical Device Product Development

A group of professionals are seated around a conference table in a meeting room at G&H ITL. They are discussing various electronic components and devices, including a large optical lens and a diagnostic medical device. Laptops, technical equipment cases, and engineering notes are spread across the table. The G&H ITL logo is prominently displayed on a screen behind them, indicating a collaborative technical or design review session.

Engineering Medical Devices from Concept to Commercialization

At G&H | ITL, we specialize in developing safe, effective, and manufacturable medical devices for global markets. With more than four decades of medical device design experience and over 600 completed projects, our cross-functional team has helped leading OEMs and start-ups turn breakthrough ideas into compliant, commercially successful products.

From surgical and diagnostic platforms to point-of-care testing and intelligent drug-delivery systems, we bring together mechanical, electronic, software, and optical expertise under one roof - accelerating development while maintaining uncompromising quality and traceability.

Integrated Design and Development Services

Our end-to-end process ensures your device moves smoothly through every stage of its lifecycle - from early feasibility to design transfer and full-scale manufacture.

Our Capabilities Include:

  • Requirements & Feasibility Analysis – capturing clinical and regulatory needs, risk assessment, and proof-of-principle prototyping.
  • System & Industrial Design – ergonomic, user-centred design that meets both functional and aesthetic requirements.
  • Mechanical, Electronics & Software Engineering – hardware, firmware, and embedded systems developed to EN 60601, EN 61010, and EN 62304 standards.
  • Design for Manufacture (DFM) – optimizing cost, reliability, and scalability.
  • Verification & Validation – testing to ISO 13485 and FDA 21 CFR 820; documented traceability through the entire process.
  • Design Transfer & Pilot Production – validated processes, operator training, and manufacturing readiness.

Built on Quality and Compliance

Every device we design is backed by our ISO 9001:2015 and ISO 13485:2016 certified Quality Management System, compliant with FDA 21 CFR Part 820. We support CE marking under MDR 2017/745 and IVDR 2017/746, and assist clients preparing for 510(k), PMA, and de novo submissions.

We also integrate ISO 14971 risk-management principles and conduct comprehensive design reviews at every phase to ensure your device is safe, effective, and regulator-ready.

Why Partner With G&H

  • 45+ years of proven experience in regulated medical device development.
  • Multidisciplinary engineering expertise across mechanical, electronics, software, optics, and human factors.
  • Seamless transition from design to manufacture within the same certified system.
  • FDA-registered facility in the UK.
  • IP integrity - your intellectual property remains fully protected.

From Prototype to Production

Whether you are designing a new diagnostic device or refining an existing platform, G&H delivers the engineering precision, compliance expertise, and manufacturing capability needed to launch successfully.

Contact our Medical Device Development Team

G&H Product Development Services