Pharmtex Medical manufactures a repositionable nitinol breast localisation wire and supplies it as a non-sterile component or non-sterile assembly to distribution partners who bring it to their own markets under their own brand. If you already hold a customer base among breast-care and radiology centres, and you already have a working registration pathway with your national regulator, this page describes exactly what a partnership with us looks like.

Who holds the CE marking

You do — under your own brand. Pharmtex Medical is not the legal manufacturer of the finished device. We manufacture the wire to your specification in an ISO Class 8 cleanroom under ISO 13485:2016. You sterilise, package, label, affix your CE marking and register the device on your market. The product reaches the clinician under your name, not ours.

This division of roles is deliberate. It keeps market authorisation where the market knowledge already sits — with you — and keeps manufacturing where twenty-five years in a single niche already sit: with us.

What you receive from us

The regulatory burden is yours. Our job is to make it light. Every distribution partnership includes:

A full supplier-qualification package compiled to ISO 13485:2016 — certification, scope, process validation summaries, change-control and traceability procedures, audit history. Everything your quality system needs to qualify us as a supplier without a discovery phase.
Technical documentation fit for submission to your local regulator — material specifications, biocompatibility rationale, design and dimensional data, and manufacturing-control evidence, structured so your regulatory team can fold it into a national dossier rather than rebuild it.
Instructions for use prepared for your regulatory framework — drafted against the requirements you actually have to meet, in the language and format your authority expects, ready for your brand and your labelling.
Samples within 48 hours of a signed mutual NDA — so your clinical evaluators can hold the product before any commercial commitment exists on either side.

Why this is available now

Following recent structural changes in this product segment at the European market level, manufacturing capacity that was previously committed has become available to new partners. We have produced this device continuously for twenty-five years, in one niche, without diversifying. The line, the tooling, the operators and the quality record are unchanged — what has changed is that we are now able to place that output with distributors who want it under their own name.

Is this right for you?

This partnership model fits you if:

You sell into breast-care, radiology or surgical oncology and already know the clinicians who use localisation wires.
You have, in-house or through a partner, the regulatory capability to register a Class IIa device on your market.
Your market recognises CE marking, or has a registration route that builds on an EU technical file.
You want a finished product to carry under your own brand — not a component to feed into your own manufacturing.

We currently work with partners on markets that recognise CE marking, including Latin America, the Middle East and Southeast Asia.

If instead you are an established device manufacturer looking for a nitinol component to integrate into a device you already own, our OEM and private label manufacturing page describes that route.

How a partnership starts

An introductory call. Your market, your registration route, the volumes you realistically expect, and what your customers currently use. No documentation required from you at this stage.
A mutual NDA. Signed both ways, so specifications and commercial context can be discussed openly.
Samples within 48 hours. Dispatched as soon as the NDA is countersigned, together with the supplier-qualification package.
Specification and terms. Configuration, documentation scope, territory and volumes agreed in writing before any production commitment.

Territory, volumes and lead times

Territorial exclusivity is discussable. Where a partner is investing in registration, clinical education and a sales infrastructure, exclusivity on that territory is a reasonable subject for the agreement. The scope and the conditions attached to it are settled case by case.

Minimum order quantities and lead times are discussed per market. A partner registering a first market has a different ramp to one adding a product to an existing portfolio, and we would rather agree terms that match your actual launch plan than publish a number that fits nobody.

The manufacturing behind it

25 years manufacturing this device category, without diversifying away from it.
ISO 13485:2016 quality management system, certified by RINA.
ISO Class 8 cleanroom production environment.
4,500 units per month current output capacity.
Zero non-conformities at the most recent audit.
Repositionable double-arch nitinol anchor, supplied in 50, 90 and 120 mm lengths.

Start the conversation

An introductory call costs you nothing and commits you to nothing. If the fit is there, samples can be in your hands within 48 hours of a signed NDA. Contact Pharmtex Medical to arrange the call, or write to us with your market and your registration route and we will reply with the supplier-qualification package outline.