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Take advantage of our end-to-end manufacturing services, established supply chain, and gain easy access to global markets without having to set up a factory yourself.
Our expert knowledge of performance materials and manufacturing processes, alongside established partnerships with machining, tooling, and fabrication experts, allows us to effectively handle all your production requirements from new product introduction (NPI), sustaining engineering, and medical device assembly to aftermarket servicing and technical support.
Production Engineering (PE) acts as a bridge between the concept and product design phase and the manufacturing phase. Whether you choose pilot production or long-term manufacturing, our highly-qualified production engineers, technicians, and operators will oversee every aspect of your project to ensure a seamless transition when ramping up to volume manufacture. Even if your device has been designed by a third-party, we will liaise directly with your design authority to get a full understanding of their manufacturing requirements and timescales for completion.
PE is also responsible for technical file audits, generating manufacturing procedures and detailed works instructions, process validation (IQ/OQ/PQ), and training production operators.
Using cutting-edge surface mount technology (SMT), we can deliver maximum flexibility regardless of batch quantity, resulting in fast turnaround and proving assurance that all PCBs manufactured perform to the highest standards. However, not everything is suitable for automation – that’s why we have a skilled in-house team of through-hole technicians too.
Nowadays, many medical devices incorporate complicated wiring harnesses and cable assemblies. Our technicians have extensive experience accommodating wiring harness and cable assemblies using both semi-automatic and skilled manual processes.
We can handle any manufacturing and assembly needs, from low-volume prototypes to high-volume production. You can count on us to deliver consistent quality and performance to reduce risk and provide added security.
Your medical device will be manufactured in a dedicated production work-cell, which becomes an extension of your company within our 3,000 m2 factory. Each cell is assigned operators, approved and controlled works instructions, tools, jigs, fixtures, and testing facilities.
Our state-of-the-art automated test and inspection equipment assures that all devices manufactured to perform to the highest standards. We use Quins to capture, inspect and record high-quality images of every PCB before they are integrated into your device. For comprehensive test coverage, we use our in-house 3D automated optical inspection (AOI) system. It’s ideal for inspecting 0201 and 01005 components, 0.3 mm pitch, process control for defect prevention, and effective quality verification.
If required, we can perform a flying probe test to provide even greater coverage for complex PCB designs for a quick turnaround.
Utilizing our trusted global network of suppliers, we can source high quality and cost-effective materials and components to meet your project requirements. Using our in-house ERP system, we can track materials, parts, and components across our supply chain to provide full traceability throughout the lifecycle of your medical device.
We have established long-standing partnerships with our suppliers, built on trust, transparency, and open communication, enabling us to be proactive if notified of any proposed supplier changes.
No matter where you are in the world, we can provide global servicing and support post-manufacture. We can undertake and manage the following:
Taking the time to understand your idea, determine the scope of work, and create a comprehensive project plan.
All successful projects start with a great plan. Together with your team, our engineers will formulate a detailed project plan outlining the most effective route forward for your device. The plan is treated as a living document and is modified and updated where needed to keep your project on track and ensure we meet your expectations every time.
Generate early design concepts and proof of principle prototypes to help identify key risk areas and establish feasibility.
With a comprehensive plan in place, it’s time to start bringing your idea to life. From user experience to industrial design and systems architecture, our concept development phase saves you time and money. Our engineers will examine the basic principles of your idea, the technology, and the regulatory requirements and generate concept designs that are not only aesthetically pleasing but satisfy the required functionality and add demonstratable value.
Refine the design and develop 3D CAD models and detailed drawings ready for pilot production prototyping and testing.
With a strong understanding of user needs and a feasible concept agreed, our skilled designers and engineers will further refine the design, creating 3D CAD models and proof of principle prototypes to test and evaluate device performance and ensure it meets specification. It’s the real “nuts and bolts” of the development process, from mechanical, electronics, and systems engineering, to software and firmware development; this is where your device begins to take true form.
Conduct verification testing on alpha prototypes to ensure your device consistently meets the specification, user needs, and intended use.
It’s time to transform the CAD model into a functional, tangible device. Utilizing prototyping methods, including 3D printing, rapid molding, and laser sintering, we can deliver small batches of alpha and beta prototypes for validation and verification, testing, and regulatory submission. At the end of this stage, your device is ready for transfer to manufacturing.
Generate detailed works instructions, set up the production work-cell, validate assembly processes, and complete technical documentation and regulatory submissions.
Our in-house Production Engineering team is responsible for the design transfer, from creating detailed work instructions and work-cell set up to process validation and operator training, ensuring a seamless transition from design and development to volume manufacturing. Even if your device is designed by a third-party, we can still support you with new product introduction.
Full-scale manufacturing, sustaining engineering, and risk management of your device within an ISO 13485 and FDA GMP accredited environment.
As an ISO-certified and FDA cGMP compliant medical device manufacturer, our customers have access to skilled technicians and resources throughout our global manufacturing sites. Your device will be assembled, tested, and packed within a dedicated, project-specific work cell, each with its own operators, work instructions, tools, jigs, fixtures, and testing areas. Our rigorous process controls and quality inspection methods ensure we deliver safe, reliable medical devices on-time and to specification.
From world-leading OEMs to small, one-person startups, we are proud to have partnered with some of the most recognized names in the MedTech industry to bring to life cutting-edge medical devices that enhance and improve the lives of patients worldwide.
Our commitment to exceeding customer expectations for quality, delivery, and service has earned us our reputation as one of the most progressive and trusted medical device design and manufacturing partners. But don’t just take our word for it. Discover why 90% of our customers choose to partner with us time and time again.
Eric Mayes, CEO, Endomag
Craig Marshall, CEO, OrganOx Limited
Sumi Thaker, CEO, Momentum Bioscience Ltd
Whether you’re looking to develop an idea or concept into a commercially viable product, or you need help progressing one specific stage of your project, we can help.