Medical-grade manufacturing.

There is a version of this page — on other sites — that lists certification numbers and cleanroom class ratings. We're not going to do that here, because certifications belong to the finished device and the notified body that assessed it, not to a moulding supplier's marketing page.

What we do offer, in plain terms: we source silicone from grades documented as suitable for medical device applications, we record the material batch against every run, and we handle moulding in a segregated cell with cleaning and gowning protocols appropriate to the work.

For every medical-grade job, you'll receive a run record listing the material batch, the tool ID, the run date, the operator, and any inspection results. That record is designed to slot into your device history file without your regulatory team needing to reformat it.

If your device has specific regulatory requirements — a defined biocompatibility standard, a specific extractables profile, a documented sterilisation compatibility — tell us at the enquiry stage. We'll spec a grade that supports what you need, or tell you honestly if we're not the right supplier for that job.