Implants and implantable components
Titanium, implantable stainless steel, PEEK or other specified materials; surface control, cleanliness, lot traceability, dimensional inspection and coordination of associated treatments.
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MedTech component manufacturing
Medical components, implants, instruments and subassemblies selected against process, traceability and the required quality file.
Discuss your project →Four MedTech areas
Choose the area matching your component to define the processes, interfaces and deliverables to qualify.
Surgery
Find Swiss manufacturing capabilities suited to the mechanical interfaces, functional surfaces and documentation required for your surgical instrumentation.
Explore this area →Dentistry
Qualify Swiss manufacturers for implant interfaces, prosthetic components and dental instrument parts defined by your technical dossier.
Explore this area →Orthopaedics
Organise drawing-based manufacture of implant components and orthopaedic instrument parts, with requirements specific to each intended use.
Explore this area →Laboratory Technology
Swiss sourcing for dosing, fluidic, instrumentation and laboratory equipment parts, from prototypes to recurring production.
Explore this area →TECHNICAL DOSSIER & SWISS SOURCING
Swiss MedTech manufacturing: selecting the right level of control and evidence
A component for a medical device must be assessed beyond its geometry. Device classification, patient contact, cleanliness, material biocompatibility, traceability, process validation and change control can turn an apparently simple machined part into a documentation-intensive project.
OVEL searches for Swiss partners against the true scope: development prototype, implant, surgical instrument, diagnostic component, subassembly, cleaning, marking, assembly or packaging. ISO 13485 may be a selection requirement, but it does not replace assessment of the specific process capability and quality file needed.
PROJECT SCOPE
Instruments and subassemblies
Turned or milled parts, mechanical interfaces, gripping features, minimally invasive surgery components, assembly, marking and cleaning requirements.
Diagnostics and medical equipment
Parts for pumps, fluidics, drives, sensors and laboratory systems, with attention to repeatability, contamination and continuity of supply.
Processes included in qualification
Machining is often only one step. Risk moves into downstream operations and their validation. Selection must cover the chain actually delivered.
- turning, milling, grinding, EDM or MIM/CIM according to geometry
- deburring, passivation, electropolishing and surface treatment
- laser cutting, welding, ablation and traceable marking
- cleaning, assembly and packaging in a controlled environment
Expected quality file
The documentation level should be defined before quotation so that cost and lead time include the evidence, not just physical manufacture.
- material certificates and lot traceability
- FAI, dimensional reports and control plan
- non-conformance and change management
- process, cleaning or packaging validation where required
QUALIFICATION CRITERIA
ISO 13485 is a filter, not a complete answer
We check whether the partner’s quality-system scope matches the outsourced operation. A general certificate alone does not demonstrate control of an implant material, special process, cleanliness requirement or cleanroom packaging.
The RFQ should allocate responsibilities: who supplies material, approves treatments, validates cleaning, retains records and reports a change of machine, subcontractor or routing. This avoids grey areas during industrialisation.
QUALIFICATION CRITERIA
What we check before making an introduction
Regulatory
classification, intended use, patient contact and customer responsibilities
Quality
ISO 13485 requirement, certificate scope and audit needs
Materials
grade, declared biocompatibility, certificates and traceability
Special processes
validation, approved subcontractors and requalification
Cleanliness
residue, particles, bioburden or controlled environment as applicable
Continuity
series capacity, second source, change control and record retention
PREPARE AN ACTIONABLE RFQ
The information needed for a technically useful response
A clear dossier prevents incomparable quotations and hidden assumptions. Send what is available for the current project stage; missing points are converted into technical questions before the RFQ is circulated.
- drawing, model, revision and applicable product specification
- intended use, device class and critical characteristics
- specified material, approved source and required certificates
- cleanliness, passivation, treatment and surface condition
- validation quantities, series volume and medium-term forecast
- quality deliverables: FAI, CoC, reports, traceability and retention
Expected qualification output
- shortlist of partners whose capability profile matches the need
- explicit feasibility questions and assumptions
- clear boundary between in-house and outsourced operations
- comparable basis for lead time, cost, quality and capacity
OVEL’s exact role
OVEL is not the workshop manufacturing the part and does not claim its partners’ certifications. We structure the requirement, search for suitable capacity in Switzerland, review the available evidence of fit and coordinate the technical exchange. The selected manufacturer remains responsible for final feasibility, its quotation, processes, inspections and contractual commitments.
FREQUENT TECHNICAL QUESTIONS
Decide faster without understating industrial risk
Can OVEL select only ISO 13485 manufacturers?
Yes when the specification requires it. Certificate scope and the fit of site and processes are still assessed separately.
Can you source implants and instruments?
The search can cover implants, implantable components, instruments and subassemblies. Selection depends on material, process, documentation and regulatory roles defined by the customer.
Is a cleanroom always required?
No. It depends on the outsourced step, cleanliness level and delivery condition. Manufacture, cleaning, assembly and packaging must be distinguished.
Who validates the process?
The manufacturer provides evidence for its process, while approval and validation responsibilities must be contractually allocated with the legal manufacturer or customer.
Can the RFQ be handled under NDA?
Yes. Confidentiality can be established before design data and sensitive regulatory information are transmitted.
OUR SECTORS OF EXPERTISE
COMPLEMENTARY EXPERTISE
Swiss watch dials
Development and production for watch brands.
→Microtechnology
Miniature components and precision assemblies.
→CNC & micro-machining
Complex parts from prototype to production.
→Precision turning & décolletage
Small turned parts, repeatability and volume.
→Connectors & semiconductors
Reliable contacts and components for critical applications.
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