Urology Device Manufacturing
Reliable, Compliant Manufacturing for Single Use Urology Devices
With over 35 years of experience in medical device manufacturing, Meridian Medical is a trusted UK partner for urology medical devices, including catheterisation systems, suprapubic catheter kits, urine drainage systems, and irrigation sets.
We work with established medical device companies as well as start-ups to deliver high-quality single-use urology products designed for patient comfort and manufactured in our UK-based Class 7 cleanroom facilities.
Overview of Meridian Medical’s manufacturing facilities:
All production is carried out in the UK and includes seven ISO Class 7 cleanrooms for product assembly and packaging. We also operate one ISO Class 8 mouldshop with 12 injection moulding machines for the production of custom plastic components, including insert and overmoulding.
We are certified to ISO 13485:2016 and ISO 14001:2015, and hold Cyber Essentials accreditation to ensure your data is secure. All devices can be supplied fully packaged, labelled, and, where required, sterilised and ready for distribution.
Urology Devices We Manufacture
Meridian Medical manufactures a wide range of urology devices for OEMs and start-ups requiring scalable, compliant, and repeatable production. Each device is manufactured to meet your design specification, with the flexibility to accommodate specific end-user requirements.
Our cleanroom facilities are fully equipped to manufacture catheters and tubing sets, supported by advanced processes including drilling, punching, induction tip forming, pad printing, RF and ultrasonic welding, and solvent, UV, and cyanoacrylate bonding.
Devices can be supplied fully packaged and sterilised in quantities to suit your distribution needs.
Example machinery includes:
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Our in-house injection moulding and cleanroom assembly capabilities ensure dimensional accuracy and consistent quality across every build.
To support customers developing new devices or transferring production, Meridian also provides Full Device Project Management, which coordinates design input, prototyping, validation, and scaled manufacturing within a single controlled process.
Learn more about our Full Device Project Management service for broader device development expertise.
Expertise in Urology Device Manufacturing
Meridian Medical combines technical precision with cleanroom manufacturing to deliver consistent results across every production batch. Our processes support both smaller-scale pilot builds for OEMs and start-ups bringing new urology devices and urology products to market, as well as high-volume production supply.
Precision Processes
Our integrated manufacturing workflow includes:
- Procurement of materials and components from approved external suppliers.
- In-house injection moulding of custom components unique to your device, including insert and overmoulding, multi-lumen connectors, Y-pieces, and custom Luer fittings.
- Semi-automated assembly within ISO Class 7 cleanrooms, using processes such as induction forming, tube drilling and skiving, printing, UV and solvent bonding.
- QC and in-process testing to confirm manufacturing integrity and ensure the device meets required performance specifications.
- Sterile barrier packaging, labelling, and final packing ready for sterilisation. Devices can be supplied in customised carton quantities to match your requirements.
Each process stage is verified under documented validation protocols.
Design and Development Support
For OEMs and start-ups requiring development input, Meridian Medical’s engineering team provides:
- Design & Feasibility guidance on material selection, functional modelling, and early-stage prototyping.
- Design for Manufacture (DFM) including optimisation for cost-effective, scalable moulding and assembly.
- Prototype and validation builds supporting pilot production, verification, and usability studies.
- Regulatory support including documentation and data packages for global submissions.
Lifecycle Management
Ongoing support includes controlled change management, risk control, and supply chain continuity, ensuring compliance, reliability, and product performance throughout the full lifecycle.
Getting Your Urology Device Market-Ready
Meridian Medical supports both established OEMs and start-ups in bringing new urology devices from concept through to commercial production. Validated cleanroom processes provide a defined pathway from prototype to sterile, production-ready supply.
We provide:
- Pilot builds within validated cleanroom environments for feasibility and verification
- Scalable production processes designed for reproducibility and compliance
- In-process testing to confirm functional performance before market launch
- Flexible tooling and material options for precise component geometry and stability
- Verified sterilisation, packaging and shelf-life processes to maintain product integrity
- Technical collaboration with OEM engineers to align specifications and qualification data
Our integrated approach helps reduce lead times, streamline qualification processes, and maintain the consistent quality required for medical device compliance.
Expertise at the Core of Every Urology Device
Every stage of Meridian Medical’s urology device manufacturing process is supported by experienced engineers, technicians and quality specialists.
Urology Device Projects We’ve Delivered
Meridian Medical has applied its manufacturing expertise to a wide range of urology medical devices, producing sterile components and assemblies for OEMs across the UK and Europe. Typical work includes precision-moulded connectors, bonded tubing sets, and complete drainage assemblies manufactured under ISO 13485 control.
Explore our case studies to see how this approach delivers consistent, compliant results for OEM partners.
FAQs About Urology Devices
Can you manufacture my specific urology device, even if it’s not listed?
Yes. We can manufacture custom urology devices, and support projects that are unique or highly specialised. Whether your device is a catheter system, drainage assembly, irrigation set or related component, we work with both start-ups and OEMs to bring your concept from prototype to full-scale production.
Can you handle fluid-path critical components and leak-sensitive designs?
Yes, our precision tooling, RF and ultrasonic welding and validated cleanroom assembly ensure leak-free joints, tight tolerances, and reliable performance for single-use and sterile devices.
Can Meridian Medical supply procedure-ready or kit-packed devices?
Meridian Medical can supply procedure-ready or kit-packed urology devices. We assemble, package and sterilise components into complete sets, ready for clinical use, whilst ensuring sterility, compliance and ease of handling.
What packaging and sterilisation options do you offer?
- Medical pouch packaging
- Procedure packs and kit packaging
- Contract packaging for products supplied to us for cleanroom assembly
- Single-process packaging as part of a wider manufacturing workflow
For sterilisation, we offer fully certified services with batch-specific certificates. Options include:
- Ethylene oxide (EtO) sterilisation with validated mixed-load cycles for cost-effective processing
- Gamma sterilisation for devices where EtO is not suitable




