Contract Manufacturing

Vosfox Medical is a small contract manufacturing organization (CMO). Our core values are Quality, Flexibility, and Respect. We provide our customers with the best quality service, we can deliver. Vosfox Medical is nearly ISO 13485 certified, and with the CEO also being the QA manager, it is ensured that quality is fully embedded in the company’s core of our company. Delivering our promises to customers on time is as important as the quality of it. See our customer’s recommendation about their opinion of us.
Our facilities and team are very flexible. When we can implement the change or request, we will implement it.
Respect is our third core value. Respect for human beings and respect for our world. Firstly, a diverse team is one driver with a good mix of male/female, cultural or religious background, sexual preferences, or age. We believe that a truly diverse team, respecting each other, adds value to us a people and to our customers. Secondly, respect for the earth and its inhabitants. We do this by reducing our electricity consumption and waste. If we can’t avoid waste, we will try to separate it for maximum recycling.

Cleanroom

Facilities

Vosfox Medical has its facilities in the centre of the Netherlands, Amersfoort. A module based cleanroom, allowing for quick expansion or re-devising it in sub areas is present. The cleanroom is ISO class 7 validated, which is usually sufficient for our contract manufacturing customers with ClassIII medical devices. Further we have a clean, not controlled production area, storage space and office spaces (also for rent). We can order all the materials for you and do supplier monitoring.

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Technologies

Vosfox Medical is specialised in polymer based medical devices. The technologies that we either have or intend to have, are all available to our customers and described in more details here. You can also contact us for technologies that although they are not listed here. If we can learn it, we will provide the contract manufacturing service. An example is powder dispersing technology that we did for one of our customers, therefore ask us what is possible and you will be surprised. Read more….

Production Development

Our engineers at Vosfox Medical have experience in process development of polymer based medical devices and components. We can support you, or do the complete production development,
– Defining an URS / Equipment selection
-Design reviews
– FAT / SAT
– Raw material selection
We can do this for processes like moulding or printing, but also for your specific process. For example have supported a customer with a powder impregnation process.

Packaging Development

If you are not sure what the best packaging material is for your medical device, Vosfox Medical can support you with packaging and labelling design as well as supplier selection. Together define the packaging requirements (such as oxygen or moisture barrier properties, mechanical integrity, sterilization Blisters, pouches, and boxes). The packaging must be suitable for the chosen sterilization method and pass the sterilization and transportation validation.|
Labels need to be designed according to the Medical Device Regulations with the right symbols and the UDI numbers. We can support you or design the labels for you.

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Quality

Vosfox medical is nearly ISO 13485 certified. All processes in our contract manufacturing will be validated. Please read our article on validation in general or validation of 3D printing specifically. We also offer Quality as a service. For more information on our quality policy and core values, please read our quality page.