Contract Manufacturing

Facilities

Vosfox Medical has its facilities in Amersfoort, Netherlands. Currently, we have two ISO class 7 cleanrooms. This is sufficient for medical device production (up to Class III implants). Additionally, we have some uncontrolled assembly and storage areas and office spaces.

Medical Device Manufacturing Technologies

Vosfox Medical specialises in sterile polymer-based medical devices. The technologies we either have or intend to have are all available to our customers and described in more detail in the technologies section. Contact us for non-polymer-based medical devices or technologies not listed here. We are open to new technologies. We will provide the contract manufacturing service if we can serve you well and safely. Ask us what is possible, and you will be surprised.

Low-Volume Assembly of Medical Devices

Vosfox Medical offers assembly services. We specialise in the low-volume assembly of table-top-sized parts. We can assemble non-electrical or electrical components. The assembled components or devices can be packaged and labelled (see below).

Packaging and labelling of Medical Devices

At Vosfox Medical, we have different packaging machines.

• Pouch sealers for plastic, aluminium pouches or pouches with one side paper/Tyvek
• Blister former and sealer for (e.g.)PET blisters with paper or Tyvek lids

Further, we can package your products in boxes, shippers and pallets. If required, we can add silicone bags, shock detection labels, temperature labels, EO, gamma or beta dots, and IFUs. 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

The sterilisation and transportation processes need to be validated initially. 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.

• Releasing products for sterilisation
• Sending products to a qualified sterilisation organisation
• Release products after sterilisation
• Organise transportation from the sterilisation organisation to any location you require (including ours).

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.