Device Assembly
Schivo assembles components to form ultra-high-quality robotic-assisted and minimally invasive surgical systems, surgical instruments and tools, and implantable devices. These products are manufactured under strict quality standards, such as ISO 13485, in FDA-registered facilities. Schivo’s data collection and tracking methodologies are key elements in its world-class quality system. Every part is 100% tested and its production history is continuously recorded to ensure traceability and regulatory compliance.
Schivo offers a wide range of medical device assembly solutions.
Sub-assembly: Schivo produces smaller, functional units for later integration into complete medical devices. These sub-assemblies can include mechanical, electrical, fluidic, or optical components, and are crucial in devices such as surgical tools and implantables. Our best-practice manufacturing system offers precision machining, laser welding or bonding, overmolding and insert molding, adhesive bonding and UV curing, and clean room assembly in its sub-assembly services.
Electro-mechanical assembly: Schivo integrates mechanical components with electrical and electronic systems to create functional medical devices. This process is critical for producing complex, high-reliability products such as diagnostic equipment, surgical robotics, and implantable devices. Schivo’s integration capabilities include sensors and PCB integration, cable and connector assemblies, and motorized actuation units.
Clean room assembly: Schivo offers in-house, controlled-environment assembly of medical devices to ensure contamination-free products meet stringent regulatory and quality standards. Assembly occurs in our ISO Class 7 and Class 8 clean rooms.
White room assembly: Schivo provides highly controlled, clean environments designed to minimize contamination during sensitive medical device assembly. Similar to clean room assembly, we provide a specific area with strict cleanliness protocols for assembling sterile or semi-sterile products.
Final device assembly: the last stage in the manufacturing process, Schivo brings components and sub-assemblies together to create fully functional, tested, and packaged medical devices. Our process is designed to ensure regulatory compliance, functional integrity, and patient safety. Schivo’s capabilities include component integration, clean room assembly, bonding and joining, functional testing, labeling and traceability, packaging, and quality control and inspection.
Market-ready assembly: Similar to final device assembly, Schivo’s process produces a fully assembled, tested, packaged medical device that is compliant with regulatory standards and ready for distribution and clinical use.