Contract Manufac-turing

Contract Manufacturing

Vosfox Medical is a small contract manufacturing organization (CMO). By (being ISO13485 certified) working according to ISO 13485, and having a CEO who is also the QA Manager, our first core value is Quality. QA is well embedded in our company. But besides quality, delivering products or services at the agreed time is equally important. We support start-ups bringing their medical device to market in a fast and efficient manner. Our small-scale production facilities allow us to be flexible and find a suitable solution in every situation. While providing service to you, we keep reminding ourselves that we work with and for people in a versatile world with many different cultures, religions, preferences, and habits. While respecting everybody’s wishes and needs, we also try to minimize our ecological footprint by reducing our electricity consumption and waste to contribute to a safe and healthy world.

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, usually sufficient for our customers’ medical devices (up to Class III implants). Further, we have a clean, uncontrolled production area, storage space and office spaces (also for rent). We can order all the materials for you and do supplier monitoring.

Technologies

Vosfox Medical specialises 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 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. An example is a powder dispersing technology that we did for one of our customers. Ask us what is possible, and you will be surprised.

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Assembly

We can assemble your medical devices or parts. This can be non-electrical and 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

We can package your medical device after production. We have a medical sealer in-house for sealing pouches. We will be able to make low volume blisters in your desired shape and seal them soon. We can package inside and outside the cleanroom, depending on the cleanliness requirements of your device.

Further, we can package in boxes, shippers and pallets. We can add silicone bags, shock detection labels, temperature labels, ETO, gamma, or beta dots if required.

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

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

Sterilization and transportation

We can organize the sterilization activities for you.

  • sending products to the validated sterilization organisation
  • release products after sterilization
  • organize transportation from sterilization organisation to any location you require.

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.

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