Complete Fabrication makes prototypes and small batches for medical device teams from its workshop in Whittlesford, near Cambridge. We work in biocompatible materials, sign non-disclosure agreements as a matter of course, and supply the paperwork that goes with the parts. The company has been trading since 1986 and is ISO 9001 certified.
What we make for medical teams
- Appearance and ergonomic models for focus groups and design reviews, finished to look like the product.
- Functional prototypes in SLA, Carbon DLS and CNC-machined plastics and metals, including solid PEEK where heat resistance matters.
- Small batches of 10 to 50 units by vacuum casting, for clinical trials and user testing where the material has to behave like the final injection-moulded part.
- Surgical guides, diagnostic housings and complex assemblies printed in SLA where accuracy cannot slip.
- Low-volume production of instrument housings and components, typically in the low hundreds, when you are not ready for tooling.
Biocompatible materials
We can run certified biocompatible materials on our Carbon DLS printers and offer equivalent resins for vacuum cast batches. For skin-contact testing or surgical trials we provide the material data you need to show the prototype meets your requirements.
Paperwork and confidentiality
- NDAs are normal here. Most medical work runs under one.
- Certificates of Conformity for manufacture and for materials are supplied as standard, provided you flag the need when you ask for a quote.
- SOPs and technical agreements: if your project needs one, we build it into the workflow rather than just agreeing to it.
What ISO 9001 covers
Complete Fabrication is ISO 9001 certified (certificate 7774, ISOQAR, UKAS). That covers our quality management system. Prototypes are not finished medical devices, so approvals remain with the device manufacturer.
Work in this field
- Samba II diagnostic device: precision casework and a rotating turret for DRW, a Cambridge University spin-out, for an infectious disease test that cuts testing time from days to hours.
- Piona self-injector: an at-home fertility injector designed to look and feel like a beauty product.
- Owlstone breath analysers: vacuum cast, self-coloured, chemical-resistant casework that bridged the trials phase into manufacture.
- IPL hair removal device: 3D printed models for focus group ergonomics testing.
How a medical project runs
- You send CAD and tell us about the requirement, under NDA if needed.
- We review the file for manufacturing issues and suggest changes before anything is built.
- We choose the process: SLA for detail, Carbon DLS for repeatable functional parts, vacuum casting for batches, CNC for the finish that has to be right first time.
- We build, finish and inspect the parts against your specification.
- We supply the certificates and data sheets with the delivery.
Frequently asked questions
Can you make prototypes that touch patients?
Yes. We run certified biocompatible materials on our Carbon DLS printers and offer equivalent resins for vacuum cast batches, so parts can be used for skin-contact testing and surgical trials. We provide the technical data you need.
Do you sign NDAs?
Yes. Strict confidentiality is standard, and most medical work runs under a non-disclosure agreement.
Can you supply Certificates of Conformity?
Yes. We supply Certificates of Conformity for manufacture and for materials as standard, provided you flag the requirement when you ask for a quote.
How many parts can you make for a clinical trial?
Vacuum casting suits batches of 10 to 50 units, in resins that mimic production-grade plastics. For larger quantities, Carbon DLS and low-volume production can reach into the hundreds without tooling.
Can you machine medical parts in PEEK?
Yes. We CNC machine components from solid PEEK for demanding thermal environments, and we recommend checking the data sheet before we start.
See also:3D printing in Cambridge, vacuum casting in Cambridge, materials and data sheets, what affects the price and rapid prototyping FAQs. To get a quote, contact us.
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