Facilities

Vosfox Medical has its facilities in the centre of the Netherlands, Amersfoort. A module-based cleanroom is present, allowing for quick expansion or re-devising it in sub-areas.  The cleanroom is ISO class 7 validated, usually sufficient for our customers’ medical devices (up to Class III implants). We also aim to get a GMP Class C cleanroom for the pharmaceutical markets. Further, we have a clean, uncontrolled production/development 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

We can assemble (parts of) your medical devices. This can be non-electrical or electrical assembly.

Our non-electrical medical device assembly services are:

• Assembly filter packages
• Spot-welding
• Labelling
• Bonding
• Crimping
• Functional testing

We can assemble your electrical devices following IEC 60601 (Medical Electrical Equipment.

Packaging and labelling

When the device or component is produced, it should be packaged immediately to protect it from contamination. Vosfox Medical has medical sealers in-house for pouches and blisters. We can support you with the design of the pouch and the blister. Especially for smaller quantities (up to 0.5 million), we can produce the blisters, so you do not have to purchase large quantities. Especially for components, it is also possible to package them in bulk (like PE or alu pouches), so they stay clean until further processing. Packaging can be done inside and outside the cleanroom, depending on the cleanliness requirements.

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.

Vosfox Medical will label your products, blisters, pouches, boxes, and shippers with the required labels and information. We possess a transfer-label printer and purchase our labels from a partnering company specialising in pharma and medical device labelling. This will ensure good quality labels.

We can organize the printing of your instruction for use and add them to the product boxes.

Sterilisation and Transportation

Initially, the sterilization and transportation processes need to be validated. Once these processes are validated, we can take care of all your needs. We can organize the sterilization and transportation processes with our qualified subcontractors and suppliers.

• sending products to the qualified sterilization organisation
• release products after sterilization
• organize transportation from the sterilization 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 3D printing process specifically. We can also support you with testing such as shelf life and biocompatibility with our Quality as a service.