Services

Process Development

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

The level of our involvement is up to you.

Packaging Development

If you are unsure what the best packaging for your medical device is, 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 be suitable for 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.

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Sterilisation Validation

When the appropriate packaging is selected, and your medical device needs to be sterile, we know to execute or support you with the sterilisation validation. The following steps are an example of what is required for a radiation sterilisation validation process;

• Determine bioburden level
• Determine your sterilisation protocol (e.g. use VDmax 25)
• Validate the bioburden and sterility testing methods
• Test bioburden samples to determine the verification dose
• Sterilise samples at the verification dose and perform a sterility test
• Perform a dose-mapping study

For ETO or steam sterilisation, these steps are different.

Packaging Validation

The integrity of medical devices is partly dependent on the packaging because it functions as a protective layer between packaging and use and during transport. Therefore, finishing the packaging validation before commercial use is essential. It is also crucial that the packaging validation tests all the packaging functions, including transportation. The following tests are part of a medical device packaging validation;

• Packaging integrity testing
• Packaging shelf-life testing
• Transportation testing
• Conditioning testing
• Compression testing
• Vibration testing
• Shock testing

We support setting up a packaging validation; however, we can also do it for you!

Quality as a Service

Besides the quality assurance activities we perform as part of our own Quality Management System, we offer to our contract manufacturing customers also additional Quality as a service.