Pharmtex Medical is an ISO 13485-certified nitinol component manufacturer based in Sofia, Bulgaria (EU). For twenty-five years, our team has focused on one material and one manufacturing discipline: nitinol component manufacturing for medical devices. We supply OEM partners across Europe and beyond. This page outlines what we manufacture, how our quality system works, and how to start a partnership. We work under strict confidentiality. Every partnership begins with a mutual non-disclosure agreement before any technical details are exchanged.
What we manufacture
We manufacture nitinol wire components for a narrow range of medical device applications, including hook wires and localization sets. We also manufacture custom shape-memory wire components used in preoperative and intraoperative device systems. Our nitinol component manufacturing capability covers wire forming, shape-setting, and 100% functional verification of every unit before release. We do not manufacture a broad catalogue of parts. Instead, we manufacture a small number of component types to a very high standard of consistency.
- Nitinol hook wires for lesion localization
- Double-arch and single-arch nitinol anchors
- Custom nitinol wire components built to a partner’s drawing and specification
Across all three product categories, the underlying manufacturing discipline is the same: precise wire forming, controlled shape-setting, and unit-by-unit verification before release. This consistency lets us support both single-use disposable components and reusable device subassemblies from the same production cell.
Why OEM partners choose Pharmtex
Most of our OEM partners come to us with one recurring problem. A previous supplier could not produce a shape-memory wire component consistently at scale. We manufacture only nitinol wire components for medical devices. Because of that focus, our quality system, tooling, and training are all built around this single discipline, rather than spread across dozens of unrelated product lines. That focus means shorter qualification timelines and fewer non-conformances during transfer. Our technical team already understands the constraints of shape-memory alloys. Partners typically start with a small evaluation batch before moving to a full supply agreement, so both sides can confirm fit before committing to volume.
Manual nitinol processing expertise
Shape-memory nitinol still rewards hand-finishing. Our manual nitinol processing approach pairs experienced technicians with documented, repeatable work instructions. Every double-arch anchor or hook wire meets the same geometry and performance envelope, unit after unit. You can read more about why this hand-finished approach matters in our article on manual nitinol processing. We have applied this same hand-finishing discipline to our own repositionable localization wire product line for 25 years. It is now available to OEM partners as a standalone manufacturing service.
ISO Class 8 cleanroom and quality system
All nitinol component manufacturing takes place inside our ISO Class 8 cleanroom, under an ISO 13485:2016 quality management system certified by RINA. Our latest surveillance audit closed with zero non-conformities. Every component is functionally verified before release. Full lot-level traceability is maintained from raw material to finished unit, supported by a documented mock-recall process. Environmental monitoring, gowning procedures, and equipment qualification are all documented and available for partner audits on request.
Because these components are built into products that enter the body, those controls are assessed against a stricter standard. Our guide to invasive medical device contract manufacturing sets out what an OEM team should expect to see documented before transfer.
Supply configurations
We offer three ways to work with us, depending on how much of the value chain you want to own. Each configuration uses the same underlying nitinol component manufacturing process; only the finishing, sterilisation, and labelling responsibilities change.
Config 01 — OEM wire component
Bulk, non-sterile nitinol wire components. You assemble, sterilise, and label under your own brand and CE marking. This is the lowest unit cost configuration. This configuration suits partners who already hold sterilisation and packaging capacity in-house.
Config 02 — Finished non-sterile assembly
Complete wire, cannula, and handle assemblies, ready for your sterilisation, packaging, and labelling. This is the fastest route to market. This configuration suits partners who want to move quickly without building new internal capacity.
Config 03 — Private label
We manufacture to your specification under your brand, with new Instructions for Use created for your regulatory framework. You own the market. This configuration suits partners who want a fully private-label product without disclosing the manufacturing relationship.
Regulatory and documentation support
Every batch we manufacture is accompanied by a certificate of conformity. In addition, full device history records are retained for the lifetime required by your regulatory pathway. We support technical file preparation with process descriptions and material certificates. We also provide relevant data package inputs where these fall within our scope of manufacture. As a result, our quality team is available to support notified body audits and customer audits of our facility. This is subject to the confidentiality terms of our partnership agreement.
Most of this documentation is agreed during transfer rather than after it, which is why the choice of a medical device design transfer manufacturer determines how much rework the first validated batch requires.
Start a partnership
If you are evaluating us as a nitinol component manufacturing partner, the next step is a short introductory call. This is typically followed by a mutual NDA and evaluation samples. Visit our repositionable breast localization wire (OEM) to see full specifications and start the conversation. Most partners complete this process, from first contact to a signed supply agreement, within three to six months. The timeline depends on device complexity and regulatory pathway.
Distributors and importers on markets that recognise CE marking can take this device to market under their own brand. Our distribution partnership page sets out who holds the CE marking, what documentation you receive, and how samples reach you within 48 hours of a signed mutual NDA.