Vosfox Medical has ISO13485:2016. We have successfully finished all three audits (phase I, Phase II, and the microbiological audit). We expect the certificate any moment now. As soon as we have our certificate, it will be placed here for downloading. We are also working towards cGMP certification to serve customers that require this. We are already working according to cGMP.
The QA requirements for producing medical devices are steep, so they should. However, ISO13485 requires risk-based processes. Our QA system is flexible. It needs to be more stringent processes for high-risk products, but it also means that we can speed up the process and reduce start-up costs where possible. We build our QMS system, so it is the most flexible and quickest to adjust to new products/processes/customers. All, of course, are subject to the quality assurance agreement (QAA).
We can perform quality control testing to ensure the product or material fulfils the agreed requirements. If we cannot do it ourselves, we can outsource it to qualified laboratories.
All our processes are validated before commercial production is possible.
Process validation. Vosfox Medical validates all production processes. We organize the validation in a way to minimize the time and samples.
Sterilization validation. We can offer a sterilization validation support service if your product must be sterilised. We can write the protocols and/or reports and organise sterilization and bioburden activities with certified sterilizing companies 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 must arrive at the user in the same state as when you released it for transportation. Therefore transportation testing is required.
Test method validation. All QC testing done must be validated testing. This is for testing using analytical or testing equipment but also for visual inspections. A GR&R (Gauge Repeatability Reproducibility) study is part of this.
QA/RA as a Service
Vosfox Medical can provide QA as a service to our customers. If you like us to provide some consulting services or perform an audit, we can. We are a member of a QA / RA specialists team; the Q-Team. This team consists of people with different specialities fields. Vosfox Medical, with the support of this Q-Team, can provide you, as a customer, with QA/RA support.