Not all production processes are plug-and-play; process development is needed to produce the medical device or components for commercial or clinical use. Sometimes we need to adjust the design, purchase new or optimise equipment, or develop tools.
When we do not have the correct production equipment in-house, customers can purchase and place the required equipment at Vosfox Medical. We can support or fully organise the selection and purchasing of the equipment. We purchase ready-to-use equipment when possible, but if not, we can optimise it. The equipment is fully incorporated into our Quality System, but the ownership stay unchanged. In our customer property form, we arrange who is responsible for maintenance, repair, and calibration, both the execution and the expense of it.
At Vosfox Medical we have equipment that require to be used with tooling. Examples are blister forming, which requires a blister mould (metal block with the required shape milled in it), or moulds for injection moulding machine.
Other examples of tools are product holders or cutting tools
These tools must be drawn with CAD program and produced. Depending on the requirements, we could 3D print these tools or have them CNC milled from aluminium or stainless steel by trusted partners.
We can do this tool development for you.
Optimisation of Equipment
Vosfox can optimise equipment for you. This can be equipment you own and placed in our facilities or equipment we own. We will ensure the equipment’s performance can be monitored and good produces good quality products. Optimisation of equipment can entail adding sensors (e.g. temperature or press), making tools, replacing parts with stainless steel parts, etc. If you want more examples of the equipment optimisation we have done, don’t hesitate to contact us.
Defining Work Methods
With new, optimised or standard equipment, we still need to define the optimal way of producing the products to fulfil the product specifications. The equipment settings, such as temperature or pressure and washing, drying, cutting, printing orientation, coating, assembling methods etc., must be defined. These work methods are validated during the process of validation.