Low volume Contract Manufacturing Medical Devices
ISO13485 – Cleanroom
ISO13485 – Cleanroom
Welcome to Vosfox Medical, a contract manufacturing organisation. We specialise in small-volume production services for medical devices. The definition of low volume is flexible; 1, 10, 1000 or 10.000 pieces.
Do you have difficulties finding a company that makes your medical device, part or consumable? Contact Vosfox Medical to see if we can assist you. We are a small, flexible company with experience in polymer production processes, translation from laboratory sample preparation to clinical production.
If we can make it, we will make it.
Vosfox Medical can translate laboratory sample preparation to clinical batch production. Before we can produce your clinical or commercial batch, several aspects require development; process development, packaging development, material and supplier selection. We can also produce development batches for you.Read on
Vosfox Medical has ISO 13485-certified facilities, including two ISO Class 7 cleanrooms, a assembly and packaging area, and a warehouse.
We have experience with medical devices up to Class III. We can use multiple technologies to produce your products; 3D printing, micro-moulding, assembling, packaging and we are willing to learn new unique techniques you have developed to produce your device, part, medical equipment-consumable, or IVD consumables.
After the development step, the validation of all processes must be done. Packaging and label validation, sterilization validation, process validation, transport validation. By complying with the regulations and customer requirements, we support our customers in getting their products to market quicker.Read on
For Vosfox Medical, Quality is the essential cornerstone of the company. We don’t just pass ISO13486 certification; we genuinely embrace it. Vosfox welcomes the necessary elements and focuses on practical implementation.
With our in-house regulatory experience, we support our customers in their development. We support our customers with label design, packaging design, and testing, but we also provide quality as a service. We can support our customers with services such as risk analysis.Read on
GATT Technologies B.V. has been working with Vosfox Medical for over 4 years. Sandra and her team had supported us with their expertise during all the design and development process of our product GATT-Patch. Their work on packaging and label selection, transportation, process improvement and validations has had a very positive impact in our project. In addition, during the last year they have been our contract manufacturer, taking care of several critical steps on the GATT-Patch production chain. We are extremely satisfied with the services provided by Vosfox Medical, their special focus on quality and their easy, supportive and pleasant way of communication. "
Director of Operations
Vosfox Medical assists JointSphere with manufacturing process development/validation as well as packaging development/validation and sterilization validation. As contract manufacturer Vosfox Medical is responsible for the final step in our manufacturing process and packaging of our implant for cartilage repair. This is not a straightforward process but Vosfox Medical managed to tackle all challenges within budget and on time. The collaboration with Vosfox Medical definitely moved our project forward.
We perceive the Vosfox Medical team as very knowledgeable, experienced, inventive and above all very pleasant to work with. What we see as an absolute advantage is their in-depth knowledge of all quality and regulatory related issues around medical device development. This blends in very well with their role as CMO.
JointSphere highly recommends Vosfox Medical as partner in manufacturing.