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.
Are you interested in our products and services?
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
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.