Medical Technology
Medical device manufacturers require biocompatible metals with full traceability, ISO 10993 compliance and documented material history from the melt to the implant. Hansemut sources nickel wire and titanium ingots from certified producers — ready for your regulatory submissions.
MedTech sourcing is a regulatory and traceability challenge.
ISO 10993 biocompatibility evidence
Regulatory submissions require documented biocompatibility of raw materials. Sourcing from unqualified suppliers creates gaps in your technical file.
Full traceability from melt to device
MDR and FDA 21 CFR 820 require complete material traceability. A broken chain of custody can block market approval of finished devices.
Dual-material sourcing complexity
Many medical devices combine nickel wire (electrodes, sensors) and titanium (implant bodies). Coordinating two separate supply chains doubles compliance effort.
Biocompatible metals with regulatory-ready documentation.
ISO 10993 material documentation
We supply biocompatibility data packages for both nickel wire and titanium. Material certificates reference applicable ISO 10993 parts for your regulatory file.
Melt-to-delivery traceability
Every spool and every bar is traceable to its melt number, production date and test results. Documentation supports MDR Annex II technical files.
One partner for Ni + Ti
Source both nickel wire and titanium ingots through a single qualified channel. One audit, one quality agreement, one point of contact for your MedTech supply chain.
Qualify biocompatible metals for your device submission
Receive Ni wire and Ti samples with ISO 10993 documentation and melt traceability — ready for integration into your MDR technical file.
How our metals serve medical device manufacturing
Implantable Device Electrodes
NP1 nickel wire at 0.05 mm diameter is used for stimulation and sensing electrodes in pacemakers, neurostimulators and cochlear implants. Full biocompatibility per ISO 10993-5 and melt-to-spool traceability support FDA 510(k) and MDR submissions.
Titanium Surgical Instruments and Fixation Plates
Titanium Grade 2 bars are machined into osteosynthesis plates, bone screws and microsurgical instruments. ISO 5832-2 compliance and EN 10204 3.1 mill certificates provide the material documentation required for Class IIa and Class III device approvals.
Compliance for medical device manufacturing
Certified quality management across all manufacturer partners.
Certificate of Analysis with complete analytics for every batch.
Verified supply chain per Conflict Minerals Policy.
Material Safety Data Sheet for every delivered product.
Materials for medical technology.
Nickel Wire NP1/NP2
Biocompatible nickel wire for stimulation electrodes, catheter sensors and diagnostic devices. Available from 0.025 mm with full traceability per ISO 10993.
Titanium Grade 2
ASTM B348 titanium for endoprostheses, osteosynthesis plates and dental implants. ISO 5832-2 compliant with mill certificate EN 10204 3.1.
Medical Technology
Medical device manufacturers require biocompatible metals with full traceability, ISO 10993 compliance and documented material history from the melt to the implant. Hansemut sources nickel wire and titanium ingots from certified producers — ready for your regulatory submissions.
Titanium Grade 2 is biocompatible per ISO 5832-2 and widely used for permanent implants. We provide mill certificates and material documentation supporting your regulatory submission.
Yes. Our documentation packages are designed for integration into ISO 13485 quality management systems. Traceability covers the full chain from melt to delivery.
Titanium from EU warehouse stock: under 48 hours FCA. Nickel wire: 2-4 weeks depending on diameter and quantity. Qualification samples ship within 5-10 business days.
More industries with the highest material standards.
Source materials for your medical devices.
Request nickel wire or titanium with biocompatibility documentation and full traceability.
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