Assembly of medical equipment in compliance with ISO 13485
Do you need an assembly partner for your medical equipment? Do you need an assembly partner for your medical equipment?
Electrolomas offers assembly services for medical technology manufacturers that need to outsource the integration of electronics, cabling, mechanics, and critical components. Electrolomas offers assembly services for medical technology manufacturers that need to outsource the integration of electronics, cabling, mechanics, and critical components.
Electrolomas offers assembly services for medical technology manufacturers that need to outsource the integration of electronics, cabling, mechanics, and critical components. traceability defined for each product.
Assembly of medical equipment in compliance with ISO 13485
Assembly of medical equipment in compliance with ISO 13485
traceability defined for each product.
after-sales support.
after-sales support.
after-sales support.
• Identification and traceability of materials, components, batches, and operations.
• Identification and traceability of materials, components, batches, and operations.
Manufacturing and assembly of medical devices
• Electrical, functional, and visual checks in accordance with customer specifications. • Electrical, functional, and visual checks in accordance with customer specifications.
Manufacturing and assembly of medical devices
• Electrical, functional, and visual checks in accordance with customer specifications.
Quality control and traceability throughout the assembly process
agreed upon with the manufacturer.
Quality control and traceability throughout the assembly process
agreed upon with the manufacturer.
Process controls
Inspections and tests defined at critical points to detect deviations before the equipment is closed.
Inspections and tests defined at critical points to detect deviations before the equipment is closed.
Inspections and tests defined at critical points to detect deviations before the equipment is closed.
<strong>2. Process definition:</strong> sequence, tooling, test equipment, and control points.
<strong>2. Process definition:</strong> sequence, tooling, test equipment, and control points.
<strong>2. Process definition:</strong> sequence, tooling, test equipment, and control points.
Process controls
<strong>5. Production:</strong> documented assembly, traceability, and functional testing.
<strong>5. Production:</strong> documented assembly, traceability, and functional testing.
<strong>6. Delivery and after-sales:</strong> packaging, dispatch, repair, and spare parts management.
<strong>6. Delivery and after-sales:</strong> packaging, dispatch, repair, and spare parts management.
<strong>6. Delivery and after-sales:</strong> packaging, dispatch, repair, and spare parts management.
• Rehabilitation, therapy, and assistive equipment.
Projects we can set up
Projects we can set up
• Rehabilitation, therapy, and assistive equipment. • Medical devices with specific requirements for traceability and testing.
Projects we can set up
• Medical devices with specific requirements for traceability and testing.
What does it mean to assemble a team under ISO 13485?
• Medical devices with specific requirements for traceability and testing.
What does it mean to assemble a team under ISO 13485?
of manufacture.
What does it mean to assemble a team under ISO 13485?
Yes. We incorporate inspections and tests defined in consultation with the client, using documented procedures, tools, and acceptance criteria.
Do you perform functional and electrical tests?
Yes. We incorporate inspections and tests defined in consultation with the client, using documented procedures, tools, and acceptance criteria.