ITL (a G&H Company) partners with medical device suppliers in designing, developing, and manufacturing devices, in-vitro diagnostics (IVD) and other technologies. We use our in-house tools, knowledge, and state-of-the-art technology to expedite the development and regulatory approval process for Class I, IIa, IIb and IVD devices.
Whether you are a new start-up or an established original equipment manufacturer (OEM), we have the flexibility and scalability to manage your project. Providing quality is essential to us and we operate a comprehensive quality management system (QMS) to control our design, development, and manufacturing process.
We operate ISO 13485-certified and US Food and Drug Administration (FDA) compliant mirrored facilities in Ashland, Virginia, and Shanghai, China. These allow us to provide our customers with international support and gain access to global supply chains and markets, as well as meet national and international specifications for safety and quality.
Our unique range of built-in capabilities can help your device progress quickly, reliably, and cost-effectively at every phase of its development.
Comprehensive medical device development services
ITL combines design knowledge, problem-solving skills and engineering expertise to create innovative design concepts. There are several factors to consider when developing a medical device such as aesthetics and differentiation, depending on ease of use and other human factors.
Our team of engineers and industrial designers works through a methodical process to refine your concept, ensuring that it is technologically and commercially viable and designed with manufacturing in mind.
High-quality medical device design and engineering
With decades of experience across multiple industries and disciplines, ITL’s world-class engineers know how to solve the most complex research and development (R&D) challenges to bringing your medical device to market.
From our adaptable, collaborative approach to our comprehensive industry knowledge and commitment to quality, we can help you develop your concept and achieve your vision through thorough designing, engineering, prototyping, and testing.
Our expertise in the design and engineering of medical equipment also covers risk management, regulatory compliance, project management, microfluidics and fluid dynamics, optics engineering, and thermal control systems.
End-to-end manufacturing for medical device suppliers
ITL’s end-to-end manufacturing services drive the supply chain and enable clients to access global markets without needing to operate their own production facilities.
From new product introduction, sustained engineering and medical device assembly to after-market servicing and technical support, our knowledge of performance materials and manufacturing processes allows us to efficiently handle all our clients’ production requests.
Using top-of-the-range surface mount technology (SMT), we can offer maximum flexibility for any batch quantity, resulting in fast turnarounds and ensuring all printed circuit boards (PCBs) perform to the highest standards.
ITL has two surface mount lines for the fabrication of PCBs, one in the UK and one in Shanghai, China. Our UK location includes the following infrastructure:
- Speedprint avi210 screen printer
- Europlacer iineo1 and iineo2 SMT Pick and Place
- Takaya APT – 1400F flying probe tester
- Blundell CMS-400 wave solder machine
- Aleader ALD7720s i3D Inline AOI
- Quins LC 20
Global medical device regulatory consulting
ITL provides expert advice on medical device regulation throughout your product’s development cycle. Our global regulatory affairs team has many years of experience working with medical devices and IVDs of all classes, and can assist with gaining access to European, Asian, and North American markets with proficiency and pace.
Companies of all sizes partner with ITL for medical device regulatory consulting due to our knowledge, certifications and resources, as well as our experience in bringing compliant medical devices to market.
ITL has served the medical device industry for more than 40 years and has been part of the Gooch and Housego (G&H) Group since August 2018. Having access to G&H’s technology, knowledge and experience has allowed us to provide design and manufacturing solutions for various medical applications, including surgical lasers, microscopy and medical imaging.