Development steps are the first steps from laboratory samples to clinical production of medical devices. Besides the product’s design, other development steps, such as process or packaging development, are also needed. Below are the steps to consider, and Vosfox Medical offers these services to you.
Our engineers at Vosfox Medical have experience developing fabrication or assembly processes of medical devices and components. We can also support you with processes like;
- Process or Equipment selection
- material selection or supplier selection
- Defining a URS
- (Equipment) Design reviews
- Scale-up of processes
- FAT / SAT (equipment acceptance testing)
If you are unsure about the best packaging for your medical device, Vosfox Medical can support you with finding suitable packaging and labels.
Together, we will define the packaging requirements, such as oxygen or moisture barrier properties, mechanical integrity and sterilisation method. Then, the appropriate suppliers and materials for blisters, pouches or boxes are selected, and a packaging design is created. The packaging must suit the chosen method and pass the sterilisation and transportation validation.
Subsequently, the labels are selected and designed. Labels must be designed according to the Medical Device Regulations with the correct symbols and the UDI numbers.
Raw Material & Supplier Selection
If you don’t know which material is best for your application, we can supply you with suggestions and perform some trials for you. Most customers know which material they want to use, as they used it during the product development phase, but only technical-grade materials were used. We can help you find medical-grade materials and reliable suppliers for:
- raw materials
- your packaging materials, silicone bags
- labels, indicators
Vosfox Medical will do the supplier selection, approval, and monitoring, and we can do supplier audits for you by our certified auditor.Read more
Pre-Clinical batch production
When you need products for testing or a study, we can produce these for you. Pre-clinical batches are not fully validated and may not be used for human use, but they have a much higher reliability than laboratory-produced samples. We can produce these samples in the cleanroom, ensure full traceability of raw materials, package them in acceptable quality packaging materials and test and record all production and test results in batch records. Vosfox Medical can arrange the sterilisation when required. We will not provide you with a certificate of Analysis or Conformity; we will mark all products with warning labels NOT FOR HUMAN USE.