Medical injection moulding with ISO-certified precision – delivered on time, every time. We specialise in producing high-quality plastic components for life-critical medical devices, ensuring full regulatory compliance and strict quality control. Our expertise in medical injection moulding allows you to focus on patient care while we guarantee every part meets your exact standards.
Reliable Production for Life-Critical Devices
When it comes to medical injection moulding, there’s no room for error. A faulty plastic component can put patients at risk and jeopardise regulatory approvals. Delays or quality issues in plastic injection moulding for medical devices could mean lost trust, recalls, or costly setbacks.
Hi-Technology Group offers the solution. Our medical device plastic injection moulding service is designed to eliminate these risks by delivering consistent, compliant parts on schedule. We combine certified processes with meticulous quality control so you get reliable components every time – safeguarding your reputation and patient safety.
- Ensure Compliance – ISO 9001 quality management supporting ISO 13485 standards means every batch meets medical device regulations
- Reduce Risk – Full traceability and strict QC at every step help you avoid recalls and failures.
- Accelerate Time-to-Market – Efficient tooling and expert guidance get your device from design to production faster.
- Guarantee Supply – Dual-site manufacturing (UK and Slovakia) provides a dependable supply chain with backup production.
How Our Medical Injection Moulding Process Works
- Consultation & Design Review: We start with your requirements. Our engineers review your design for manufacturability, offering tweaks so your medical plastic components are optimised for injection moulding (ensuring fit, function, and compliance).
- Tooling & Material Selection: Next, we develop precision mould tools and help select the right medical-grade plastic (e.g. biocompatible polymers) for your project. Every tool is qualified, and materials vetted to meet healthcare standards.
- Moulding & Quality Control: We then mould your parts in our controlled production environment. Each run follows strict process controls with ISO 9001-certified workflows and full traceability to ensure every piece meets specifications. Inline inspections and testing minimise defects and ensure every component meets specification.
- Assembly & Packaging: If your project requires it, we can assemble components and even package them with your instructions or IFUs. This can be done in a cleanroom environment (Class 8) to maintain sterility for critical devices. We support assembly, labelling, and packaging for regulated applications.
- Delivery & Ongoing Support: Finally, we deliver your order on time, whether you need just-in-time batches or scheduled shipments. With facilities in both the UK and EU, we ensure fast delivery and continuity. Our support continues as you scale up or refine your product – we’re with you for the long term.
Ready to see this process in action for your project? Book a call with our team to discuss your medical injection moulding needs.
What You Get
When you partner with Hi-Technology Group, you get a comprehensive, turnkey injection moulding solution tailored to medical manufacturing.
- Design for Manufacturing Assistance – We help refine your designs for optimal mouldability, catching issues early so you save time and avoid costly redesigns.
- Precision Tooling & Moulding – High-quality mould tools and tightly controlled moulding processes ensure consistent, high-precision parts with every run.
- Medical-Grade Materials – Guidance on selecting and sourcing certified medical-grade plastics (e.g. PC, PP, ABS, PEEK) that meet biocompatibility and regulatory requirements for your device.
- Dedicated Assembly solutions – For sensitive applications, we offer production in a controlled environment with bespoke assembly and testing equipment.
- Rigorous Quality & Traceability – You receive full QA documentation: material batch records, inspection reports, and traceability data aligned with ISO 13485 expectations, giving you confidence in every shipment.
- Flexible Batch Sizes – Need a small prototype run or high-volume production? No problem. We accommodate flexible batch sizes – ramp up or scale down as needed.
In short, you get peace of mind that your project is handled from concept to finished product, with the quality and care it deserves.
Why Choose Hi-Technology Group?
Medical Injection Moulding FAQs
What is medical plastic injection moulding?
Medical plastic injection moulding is the process of manufacturing plastic components used in medical devices and healthcare products using injection moulding.
It involves strict quality controls, biocompatible materials, and often specialised controlled environments to meet regulatory standards. In short, it’s medical injection moulding tailored to the high-stakes needs of medical devices.
Why use plastic injection moulding for medical devices?
Plastic injection moulding is ideal for medical devices because it can produce highly precise and complex components at scale with consistent quality. For life-critical equipment, this means each part is virtually identical and reliable.
Additionally, medical-grade injection moulding supports the use of special polymers that are biocompatible and sterilizable, making it easier for you to meet safety regulations while keeping production cost-effective for large quantities.
What materials are used for injection moulding medical parts?
When plastic injection moulding medical parts, we work with a wide range of medical-grade plastics, including commonly used polymers such as polycarbonate, polypropylene, and other engineered resins suitable for biocompatible applications.
The choice of material depends on your device’s requirements – for example, polycarbonate for transparent parts like syringes or ABS for durable monitor housings. We’ll help you select the right material that meets both performance and regulatory requirements.
Are you certified for medical device injection moulding?
We are ISO 9001:2015 certified, and we operate our medical projects in line with ISO 13485 principles. While ISO 13485 certification is typically held by the device manufacturer, our processes support your compliance by providing full material traceability, process documentation, and rigorous quality control.
In practice, this means our injection moulding service satisfies the high-quality and regulatory standards required for medical device components.
Do you offer prototyping or low-volume runs?
Absolutely. We can produce prototypes and low-volume runs for your medical device components to support R&D, clinical trials, or initial market launch. Our flexible approach means you’re not locked into massive orders – you can order small batches to test and refine your design.
Once you’re ready to scale up, we seamlessly ramp to full production. This flexibility, with no long-term commitment, helps you innovate faster and manage costs effectively.
Ready to Start? Get Your Custom Quote Today
Every day you wait is time your competitors might be moving ahead. Take the next step now – secure a reliable manufacturing partner for your medical injection moulding needs. Request a quote today via sales@hitechltd.com or call our team on 023 9278 8887 to discuss your project. We’re here to help you deliver safe, high-quality medical products on time – every time.
