MEDTECH · ORTHOPAEDICS
Organise drawing-based manufacture of implant components and orthopaedic instrument parts, with requirements specific to each intended use.
Discuss your project →An implant component and a part for an implantation instrument require different qualification dossiers. Loads, interfaces, materials and evidence are defined by the device owner. OVEL converts these requirements into criteria for identifying Swiss manufacturers and coordinates their industrial assessment.
Bone screws, fixation elements and mechanical interfaces need detailed drawings covering threads, seating surfaces, drive features and edges. Material and finishing requirements follow the approved design dossier.
For prosthesis parts and other implant components, selection considers complex geometry, datums, surface condition and stability after processing. The workshop is assessed against the characteristics actually required by the design.
Tool holders, guides, handle parts and locking mechanisms are evaluated against assembly, loads and planned reprocessing. Ergonomic or visible surfaces need acceptance criteria distinct from those for functional bearing or seating surfaces.
The enquiry should specify exact grade, metallurgical condition, documented provenance and material certificate requirements. Titanium, stainless steels and specialist alloys are not interchangeable without approval. The manufacturer confirms that machining and finishing capabilities suit the dossier.
A process can combine turning, multi-axis milling, secondary operations, deburring, polishing and marking. Critical areas must remain measurable after finishing. The offer identifies surface processing, required protection and responsibility for subcontracted operations.
A dimension that conforms before finishing may change during polishing or surface treatment. The inspection plan defines the condition in which each characteristic is checked and the methods used for profiles, threads and difficult-to-access surfaces.
Fatigue, strength and other device performance evaluations are separate from dimensional inspection of a component. The device owner defines and validates those requirements. OVEL helps clarify the deliverables requested from manufacturers and specialist providers along the supply chain.
Pilot production should document a reproducible process and production conditions. Material, supplier and process changes, deviation handling and batch identification are addressed before launch. If ISO 13485 is specified, the manufacturer’s certificate and covered activities are reviewed during selection.
Include revision-controlled drawings, 3D data, intended component use, interfaces, material, critical surfaces, quantities, cleanliness and required reports. OVEL searches for appropriate capabilities and coordinates technical exchanges. Manufacturers and the device owner retain their respective production, design and validation responsibilities.
Discuss your project →Yes, provided specifications, acceptance criteria and deliverables are separated for each component family.
No. It establishes conformity only for the characteristics measured. Device performance requires the evaluations and validations defined by the device owner.
At the feasibility stage. Finishing can affect dimensions, surfaces and inspection strategy; adding it late may require a revised manufacturing process.
Find Swiss manufacturing capabilities suited to the mechanical interfaces, functional surfaces and documentation required for your surgical instrumentation.
Explore this area →Qualify Swiss manufacturers for implant interfaces, prosthetic components and dental instrument parts defined by your technical dossier.
Explore this area →Swiss sourcing for dosing, fluidic, instrumentation and laboratory equipment parts, from prototypes to recurring production.
Explore this area →OUR SECTORS OF EXPERTISE
Development and production for watch brands.
→Miniature components and precision assemblies.
→Complex parts from prototype to production.
→Small turned parts, repeatability and volume.
→Reliable contacts and components for critical applications.
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SWISS INDUSTRIAL SOURCING