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Medical device development demands more than standard prototyping. Materials need to meet biocompatibility requirements. Parts need to be traceable. And when a programme has a clinical milestone to hit, the supplier needs to deliver reliably and on time.
Prototype Projects has supported medical device and life sciences teams for decades, producing prototypes, test parts and low-volume production components for programmes ranging from early proof of concept through to clinical validation and pilot production. Our facility in Royston, Hertfordshire, is ISO 9001 and ISO 14001 accredited, and all work is carried out in-house, in the UK.
We hold USP Class VI-capable SLA resin in stock and offer micro 3D printing in a biocompatible, sterilisable resin that has passed six ISO 10993 biocompatibility tests. For programmes requiring metal or high-performance polymer parts, our CNC machining service covers PEEK, stainless steel, aluminium and acetal. And for products moving toward production, our UK-made injection mould tooling and low-volume moulding service supports the transition from prototype to pilot run.
USP Class VI-capable SLA material Our Accura ClearVue SLA resin is USP Class VI capable – suitable for prototype parts requiring limited contact with the body. Parts are cleaned and packaged to our in-house protocol. No post-processing operations are carried out on USP Class VI parts.
ISO 10993-tested biocompatible resin for micro 3D printing Our BIO resin for micro 3D printing has passed six ISO 10993 biocompatibility tests, including skin irritation, sensitisation, cytotoxicity, pyrogenicity, acute systemic toxicity and in vitro hemolysis. It is suitable for non-implantable medical applications and can be sterilised.
CNC machining in PEEK and other engineering materials PEEK is the material of choice for many medical device components requiring high-temperature performance, chemical resistance and biocompatibility. We machine PEEK, stainless steel 316, aluminium and acetal as standard.
Micro 3D printing for small, detailed components Our micro 3D printing capability produces features down to 0.1 mm – relevant for the miniaturised, intricate geometries common in drug delivery devices, diagnostics and surgical instruments. Available in BIO and other materials.
Injection moulding for pilot production For programmes moving from prototype to production, we offer UK-made tooling and low-volume injection moulding in a range of medical-grade and standard polymers. Keeping toolmaking and moulding under one roof reduces the risk of knowledge loss between development stages.
ISO 9001 accredited quality management Our quality management system is independently accredited, providing the process control, traceability and documentation that regulated development programmes require.
UK-based, in-house, confidential All work is carried out at our Royston facility. Your files and part data are stored on our own server with encrypted cloud backup. Full confidentiality is maintained as a matter of course.
Every project is managed by our experienced team, ensuring consistent communication, clear timelines and dependable quality throughout.
When your in-house facilities reach their limit, we extend your capability providing speed, reliability and UK-made assurance.
Contact our team on 01763 249760 to discuss your next project, or request a quote using the form below.
Please Note: requests for our 3-Day production speed must meet our 3-Day criteria. All final data for our 3-Day production speed is required by 4.30pm.
To request a quote for any of our other technologies/services, such as Vacuum Casting, Model Making and Laser Cutting, please complete this contact form.
