Vosfox Medical is in the process of obtaining ISO13485:2016. We are proud to tell you that our phase I and Phase II audits went well. Unfortunately the microbiology audit is delayed due to Corona lockdown. As soon as we have our certificate it will be placed it here for downloading .
We are also working towards cGMP certification to serve customers that require this. We are already working according to cGMP.
You can get the QA/RA support you want. Of course we will perform required process validation activities, but we can provide so much more.
Sterilization validation. If your product must be sterilized, we can offer sterilization validation support service. We can write the protocols and/or reports, organise the sterilization and bioburden activities with certified sterilizing company and microbiology laboratories.
Packaging validation. If your packaging serves as a sterile barrier, the integrity of the package system must be tested.
Transportation testing. Your medical device, arriving at the user, must be in the same state as it was when you released it for transportation. Therefore transportation testing is required. A commonly used test is the ISTA testing.
General QA and RA services. Vosfox Medical is member of a team of QA / RA specialists Q-Team NL. This team consists of people with different specialities fields, who can support Vosfox Medical and you as customer with a wide variety of Quality Assurance or Regulatory Assurance question.