Bringing Instruments to LifeOVER 40 YEARS’ CO-CREATING PIONEERING MEDICAL TECHNOLOGY

Email us ask@itl.co.ukTo find out more, please visit www.itlmedical.com Email us ask@itl.co.uk 3

About usEstablished in 1977, ITL Group (a Gooch & Housego Company) is the award-winning contract design, development and manufacturing partner for companies developing a range of products including life-saving medical technology. For more than 40 years ITL has provided innovative and reliable solutions to complex systems engineering and manufacturing challenges.

Based in Ashford, Kent, UK with operations in the US and China, ITL provides a world-wide full product development, design, manufacturing and aftersales service for the commercialisation of medical, diagnostic, analytical and laboratory instruments, including systems.

With customers ranging from start-ups to market-leading organisations, ITL maintains a flexible and collaborative approach to product development and is committed to exceeding customer expectations for quality, delivery and service.

To find out more, please visit www.itlmedical.com2

4 5Email us ask@itl.co.ukTo find out more, please visit www.itlmedical.com

What We DoBringing instruments to life

Product DevelopmentEvery world-leading innovation started with an idea

Whether you’re looking for a company to develop an idea or concept into a commercially viable product, or you need help progressing one specific stage of your project, ITL can help.

We offer clients a portfolio of services, from R&D and full-scale manufacturing to aftersales servicing and support, all delivered to the highest standards by our experienced team.

ITL can help you to realise your vision and progress your initial concept through detailed design, further development, prototyping and testing. Working through a methodical product development process, ITL will refine your concept to make sure all requirements are commercially and technologically viable.

With over 40 years in the industry, we know what will work, what won’t and what requires fine tuning. Our team’s expertise and specialist know-how gives the product development process structure, efficiency and speed.

ALTHOUGH EVERY PROJECT IS UNIQUE, OUR PRODUCT DEVELOPMENT ACTIVITIES INCLUDE:

• Concept generation

• System requirements specification (SRS)

• System concept design architecture (SCDA)

• CAD modelling and Proof of Principle (POP) prototypes

• Risk analysis and regulatory compliance

• Draft cost models

OUR SERVICES INCLUDE:

• Product Development

• Product Design

• Manufacturing

• Regulatory and Product Development Consultancy

• Aftersales Servicing and Support

6 7Email us ask@itl.co.ukTo find out more, please visit www.itlmedical.com

From aesthetics and differentiation to usability and human factors, there’s a lot to consider when designing your medical device or IVD. At ITL your project will be undertaken by a dedicated team with the required skill-set for your project. Our multi-disciplinary team consists of experienced and skilled engineers who ensure that you enter the market with not only a life-changing concept, but an expertly designed product that’s intuitive for the end user.

The product design stage is where your product first comes to life and can be used in trials, further testing (including EMC and safety testing) and regulatory submission - all of which ITL can support you through.

Product DesignPutting patient needs first with exceptional product design

ManufacturingProviding the tools you need to bring a medical device to life

From component procurement to logistics, our manufacturing service spans the entire supply chain. ITL proudly maintains a highly controlled Quality Management System and is audited and accredited to ISO 9001, ISO 13485 and FDA CFR 21 part 820.

Working with us to manufacture your product means not incurring infrastructure costs and avoiding the risks associated with doing it all in-house, it will also give you access to established global supply chains, manufacturing facilities and new markets.

A combination of automation, skilled manual assembly and testing means that our capabilities extend beyond low volume manufacture, with manufacturing capacity for thousands of units per month.WE HAVE WORKED ON A WIDE

RANGE OF INSTRUMENT AND DEVICE FORMATS, INCLUDING:

• Bench top

• Floor standing

• Handheld

• Patient connected

• Cartridges/Disposables

OUR MANUFACTURING CAPABILITIES INCLUDE:

• Initial Device Master Record Validation (for products not designed by ITL)

• Production Engineering

• Pilot Manufacturing

• Procurement and Supply Chain Management

• PCB, Wiring and Cable Loom Manufacture

• Global Servicing and Support

• Logistics

8 9Email us ask@itl.co.ukTo find out more, please visit www.itlmedical.com

We can support you through every stage of your product development lifecycle. Our consultancy service allows you to tap into the knowledge of our experienced team who can advise you on how to navigate the complex regulatory landscape of medical and IVD devices.

ITL maintains a highly controlled quality system that incorporates appropriate quality gates throughout the process of bringing your instrument to life. This framework allows us to support our customers on a full project or adhoc consultancy basis using our tried and tested regulatory system.

With facilities in the UK, US and China, we offer you and your end-users world-wide support whether or not your device was designed or manufactured by ITL.

We see ourselves as your partner throughout your product’s journey, from concept realization to a product destined to improve the lives of patients worldwide.

Regulatory & Product Development ConsultancyHelping secure the future of your medical device

Servicing & SupportHelping increase your device’s chance for long-term commercial success

ITL CAN ADVISE AND HELP YOU WITH THE FOLLOWING:

• Technical support for funding & grant applications

• Project status reviews & reports

• Full technical file audit

• Manufacturing package audit

• Regulatory compliance assessment

• CE marking, FDA & CFDA regulatory accreditations

• Logistics

• Technical phone support

• Upgrades

• Servicing

• End-user training

• Refurbishments

• Repairs

• Redesign

• Value engineering

• Technical file maintenance

• Obsolescence mitigation

ALTHOUGH EVERY PROJECT IS UNIQUE, WORKING WITH US WOULD INVOLVE:

10 11Email us ask@itl.co.ukTo find out more, please visit www.itlmedical.com

Vitl Life Science Solutions specialises in the design, development and manufacture of high-end laboratory and analytical instruments.

From best-selling microplate heat sealers, to a collection of programmable mixers, shakers, vortexers and readers; Vitl products are suitable for a breadth of applications including, ELISA, DNA isolation, enzymatic reactions and sample incubation.

Vitl is committed to supplying world-leading products to the life science industry with a growing portfolio that is highly regarded for its durability, reliability and efficiency. All products are available through a global network of distributors and trusted OEM partners.

With an unrivalled level of sample care, usability and repeatability, Vitl products are used in laboratories world-wide including, the United States Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), Mayo Clinic and the New York State Department of Health.

Our parent company, Gooch & Housego, is a photonics technology business headquartered in Ilminster Somerset, UK with operations throughout the USA and Europe.

A world leader in its field, the company researches, designs, engineers and manufactures advanced photonic systems, components and instrumentation for applications in the Aerospace & Defense, Industrial, Life Sciences and Scientific Research sectors. World-leading design, development and manufacturing expertise is offered across a broad range of complementary technologies.

Vitl Life Science Solutions About G&H

To find out more about Vitl Life Science Solutions, please visit www.vitlproducts.com.

To find out more about G&H, please visit goochandhousego.com.

• Acousto-Optics

• Electro-Optics

• Fiber-Optics

• Precision Optics

• RF Electronics

• Instrumentation

Across ten sites G&H make photonic assemblies, systems and components based upon the following key enabling technologies:

Find G&H on Twitter and LinkedIn:

@ghphotonics

linkedin.com/company/gooch-&-housego

Find Vitl on Twitter and LinkedIn:

@VitlProducts

linkedin.com/company/vitl-life-science-solutions

www.itlmedical.com

EUROPE

Integrated Technologies Limited, Viking House, Ellingham Way, Ashford, Kent, TN23 6NFTel: +44 (0)1233 638383 Email: ask@itl.co.uk

USA

ITL (Virginia) Inc, 395 Ashcake Road, Suite L, Ashland, VA 23005, USATel: +1 804-381-0905 Email: sales@itlva.com

CHINA

Integrated Electronic Systems (Shanghai) Co Ltd, Jinqiao Export Processing Zone, Pudong Shanghai 201201, ChinaTel: +86 (21) 58585463 Email: sales@ieschina.com Find us on Twitter and LinkedIn:

@IntTechLtd

linkedin.com/company/itlgroup