Component supply for existing devices
You have a validated device and need reliable component supply. We slot into your existing supplier controls with the documentation you already require.
For medical device makers and their regulatory teams
For medical device makers.
You're building a device. Silicone is in it. Your notified body or regulatory pathway needs to know what the material is, where it came from, how it was handled, and how you'd prove that if asked. We run the supply side of that conversation.
How this works, plainly
We don't claim your certifications. We give you what you need to hold yours.
The regulatory certificate belongs to your device, held by you and your notified body. A moulding supplier's job is to give you the material and process documentation you need to close out your device history file, not to claim a compliance status that doesn't belong to us.
In practice, that means: we source silicone from grades documented as suitable for medical device applications, with the supplier's technical data sheet and biocompatibility documentation on file for every batch. We record the material batch against every run of your part.
We run medical work in a segregated cell — separate tools, separate handling equipment, separate cleaning protocols. Gowning and glove protocols appropriate to the work. No cross-contamination from general silicone or rubber production.
Every batch ships with a run record listing material batch, tool ID, run date, operator, and any inspection outcomes. Designed to attach to your device history file without your regulatory team needing to reformat it.
What you'll get on a medical programme
Three consistent deliverables.
A material specification, signed off
The grade you're using, its supplier documentation, its biocompatibility posture — all agreed and recorded before the first run.
Batch records against every run
Material batch, tool ID, run date, operator, inspection outcome. Formatted for your device history file.
A predictable supply relationship
Named engineer, defined communication cadence, any upstream material change communicated to you before it hits a batch.
What we deliver for medical customers
Four types of engagement.
Development for new devices
You have a design in development. We collaborate on manufacturable geometry, grade selection, and the documentation package your regulatory pathway will need.
Contract manufacturing of full silicone sub-assemblies
Moulded parts plus finishing, printing, sub-assembly and inspection — delivered as finished sub-units to your device assembly line.
Long-run continuity for approved parts
Once a part is validated, we hold it stable across years. No unauthorised material changes, no drift on colour or feel, no surprises at your incoming inspection.
How we'd deliver
The services this sector uses most.
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Where else we work.
Designed and developed in the UK. UK moulding capability, with some higher-volume production placed with trusted partners where that's the right commercial answer.
Get in touch
Tell us the part, the volume, and the timeline.
Rough annual volume, target unit price, and any deadlines. That's enough to work out whether compression, LSR injection or something else is the right tool.
Real people, a real workshop
You deal with the people who make it.
No call centre and no middlemen. When you contact TCI Products, you speak to the team who design, build and check your mould.
- A real Warwickshire workshopUnit 15, Waterloo Park, Bidford-on-Avon, Alcester B50 4JG.
- Real people on the phoneCall the team on 01789 224228, Monday to Friday.
- The same team on every jobDesign, production and aftercare come from the people you see here.
- Part of TCI GroupFive specialist brands, one engineering team. Visit TCI Group.
Thomas LaneManaging Director
George PrestonDesign & Project Manager
Kelly BallingerHead of Partnerships
Jim AndertonProduction Manager
TheodoreEmployee Welfare