Contract Manufacturing

Facilities

Vosfox Medical has its facilities in the centre of the Netherlands, Amersfoort. Currently, we have two ISO class 7 cleanrooms. This is sufficient for medical device production (up to Class III implants). Further, we have a clean, uncontrolled Assembly area, storage space and office spaces.

Technologies

Vosfox Medical specialises in polymer-based medical devices. However, we can use all types of materials. The technologies we either have or intend to have are all available to our customers and described in more detail here. You can also contact us for technologies that are not listed here. If we can learn it, we will provide the contract manufacturing service. Ask us what is possible, and you will be surprised.

Assembly

Vosfox Medical offers assembly. We specialise in minor volume assembly of table-top-sized parts. We can assemble non-electrical or electrical assemblies.

Packaging and labelling

At Vosfox Medical, we have different packaging machines.

• Pouch sealer for plastic and aluminium pouches
• Pouch sealer for pouches that are paper/polymer based for EO/steam sterilisation
• Blister former and sealer

Further, we can package in boxes, shippers and pallets. If required, we can add silicone bags, shock detection labels, temperature labels, ETO, gamma or beta dots and IFU. We can ensure that all pouches or blisters are labelled.

We package products that are produced at Vosfox Medical, or we do the packaging as a service.

Sterilisation and Transportation

Initially, the sterilisation and transportation processes need to be validated. Once these processes are validated, we can handle all your needs. We can organise the sterilisation and transportation processes with our qualified subcontractors and suppliers.

• Sending products to the qualified sterilisation organisation
• Release products after sterilisation
• Organise transportation from the sterilisation organisation to any location you require.

Quality and Regulatory support

Vosfox Medical is ISO 13485 certified. All processes in our contract manufacturing will be validated. Please read our article on validation in general or validation of the 3D printing process specifically. We can also support you with testing such as shelf life and biocompatibility with our Quality as a service.