Final assemblies of medical devices and electromechanical assemblies for diagnostic applications
At Schivo, our real value add is the supply of finished devices to our customers. We can machine the complex components, partner with suppliers of elements of our customers device that are not within our capability and bring the product together in our assembly operations to deliver the finished device solution to our customer.
- Final Assembly
- Testing & Inspection
- Packaging & Labelling
- Sterilization Management
- Regulatory Support
We have extensive experience and capabilities in the final assembly of direct patient contact medical devices and electromechanical assemblies for diagnostic applications and patient care applications. This assembly is undertaken in both our white room assembly areas and our validated ISO class 7 & 8 suite of cleanrooms. We implement our assembly operations in consultation with our customers and in many instances design and develop product test methods in partnership with customers at the product implementation phase.
Testing & Inspection
As a well-established manufacturing facility, we have extensive capabilities and technologies for the inspection of components manufactured, from standard metrological techniques right up to coordinate measuring machines (CMM) and advanced vision inspection systems. Additionally we routinely develop product specific inspection and verification methods with our customers on a case by case basis.
Packaging & Labelling
In the Medical Devices industry, packing and labelling can often be as important as the actual products- and with good reason. In the first instance, all our products are manufactured in the first instance under the control of our SAP production management system. And our ISO 13485 quality management system oversees this. Each customer has different requirements, and we therefore implement a packing & labelling solution in consultation with customers at the commencement of a product introduction
We have partners that support us where a customer requires us to supply a sterilised product, and we can discuss your sterilisation requirements during the project scoping phase.
We hold a number of CE mark technical files for US based customers who have chosen us as their manufacturer within the EU (supplying their products directly to customers globally). As we have strong relationships with the regulatory bodies within both Ireland and the broader EU community we support customers in their regulatory requirements.