Assembly of components & complex parts for medical technology

In addition to the production of silicone products, Siltec offers the production and assembly of components and complex parts for medical technology. Siltec has a wide range of possibilities to complete and refine individual components with further manufacturing processes. This includes manufacturing products made of thermoplastics in combination with silicone.

Siltec’s manufacturing spectrum can cover the production of various products and solutions, such as: silicone tubing systems, tubing sets, catheters, components with integrated electronic components or complete assemblies. Furthermore, products can be individually marked and packaged for end-user application. Furthermore, in coordination with customers, we also offer the possibility for clean room production including packaging.

Siltec’s customers appreciate the flexibility, reliability and quality of the production. Siltec works closely with them to enable fast delivery times and customized solutions. In addition, Siltec offers compliance with important standards in the medical sector. For example, manufacturing is certified in accordance with ISO 13485 and, if required, can be registered with the U.S. Food and Drug Administration (FDA) under Part 21 CFR 820 for specific items.

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Service offering for medical technology

Siltec has an extremely comprehensive range of services for customers in the medical industry. Siltec can offer different and versatile manufacturing steps for further processing various components:

  • LSR injection molding and silicone extrusion

  • Packaging and, if necessary, clean room production

  • Soldering and punching

  • Laser marking for individual labeling

  • Over-molding of electronic components (potting)

  • Automated or manual packaging, incl. packaging for end customers

  • Injection molding of thermoplastic components within the company group

  • Manual processing

Upon agreement, Siltec can take over further process steps. Please contact us to discuss your requirements.

Experience in manufacturing complex, medical components

In a variety of projects, Siltec has produced, assembled and packaged multi-layered components for medical technology. This includes for example:

  • Heatable ventilation tubes and surgical tubes in which a heating line is added to a silicone tube

  • Over-molding (potting) of an electronic sensor with a silicone sleeve

  • Silicone sealing caps in which individual, small holes are punched

  • Labeling of various medical devices by laser marking (incl. UDI according to new MDR requirement)

  • Packaging of silicone molded parts (nasal masks, binasal prongs) for premature & newborn infants in blister bags in the clean room

Silikon Gesichtsmaske Thermoplast KomponentenSilikon Gesichtsmaske Thermoplast Komponenten
Silikonprodukte QualitätskontrolleSilikonprodukte Qualitätskontrolle

Legal standards for the production of medical components

The production of Siltec has an ISO 13485 certification. The requirements of the new MDR can be met. In addition, Siltec can register as a contract manufacturer of individual items with the American FDA upon request.

Depending on the requirements Siltec also offers components according to these standards and certificates:

  • USP Class VI and EP 3.1.9

  • ISO 10993 (e.g., for cytotoxicity or skin irritation)

  • BfR XV and FDA §177.2600

  • RoHs

  • REACH

The required conformity depends on the respective area of application and the requirements of the component. We will be happy to advise you on this with our experience and expertise.

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