Device assembly
Seamless medical device and combination product assembly, no matter how complex or custom, to meet your end market requirements
We can make your complex medical device assembly seem simple
We not only understand the unique challenges and strict requirements of surgical, orthopedic, diagnostic, drug delivery and combination devices, we have the expertise, flexibility and creativity to address them with novel assembly solutions.
Accelerate market entry with customized assembly lines
One size does not fit all – and with rapid advancement of digital manufacturing technologies at our fingertips, it’s no longer necessary or cost-effective to work that way.
That’s why we flex around your device’s specific requirements, offering a range of manual to fully automated assembly services depending on material, complexity and volume. We can perform assembly-only projects for you, or integrate this as part of our end-to-end offering, which includes award-winning design and development, manufacturing, kitting and sterilization management.
A selection of our expansive assembly services
A global presence for your regional success
At every step, our assembly projects benefit from the highest quality support from our passionate, proactive and growing teams on 3 continents, including regulatory consultancy, supply chain management and project management services.
We confidently handle the assembly of all kinds of devices, from straightforward off-the-shelf to first-of-their-kind bespoke products, with cutting-edge facilities in Europe, the US and Malaysia to support geographical expansion and cost-effective project delivery.
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FDA and ISO 13485 compliant
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ISO class 7 and 8 cleanroom for assembly of Class II-III medical device
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Good Manufacturing Practice (GMP) for drug delivery & combination device assembly
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Verification and validation tensile, compression, torque & leak testing
Drug delivery and combination devices
The growing demand for small to medium volumes of drug delivery systems that support advances in specialist areas comes with its own set of speed-to-market challenges. You need an agile, flexible partner who can also meet the standards and regulations required.
Our in-house assembly procedures are compliant with global medical device and pharmaceutical requirements, taking place in dedicated ISO 7 and ISO 8 / grade B, C and D cleanrooms, and under Good Manufacturing Practices.
Plus, our drug handling licence enables us to undertake secondary packing across a range of drug delivery devices including vials, pre-filled syringes, inhalers and autoinjectors.
Far beyond assembly
Aside from standalone assembly projects, we specialise in simplifying your entire project delivery, from smarter device design and design for manufacture, to component injection molding, sterilization management and supply chain optimization.
Contract Manufacturing
Your pharmaceutical, medical device or combination product is always in safe hands with us. We adapt quickly to your unique requirements and find creative solutions to meet your critical deadlines. Always with high standards of service, quality and compliance in mind.
Let’s join forces for smoother assembly
You have manufacturing pain-points. We have problem-solving experts ready to put a plan of action together. Get in touch for a chat.