Quality Assurance is one of Vosfox Medical’s Core Values. We have an ISO13485:2016 certificate with the number MD 718621 and the following scope:
Contract manufacture and sterile-barrier packaging of 3D printed plastic-based implantable and non-implantable medical devices and components.
We are also working towards cGMP certification to serve customers that require this.
The QA requirements for producing medical devices are steep, as they should be. Our QA system is flexible and risk-based because our processes are more stringent for high-risk products, but we do not want to overdo it for low-risk processes. This principle reduces costs. We have a flexible QMS to add new products, processes and customers quickly. The quality assurance agreement (QAA) ensures no misunderstanding between Vosfox Medical and our customers on quality issues.
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.
Vosfox Medical has an internal audit plan to audit our own processes. The QMS is audited yearly by our notified body, BSI. Supplier audits are done in agreement with our customers. We can offer to audit the suppliers and subcontractors, but customers can also keep this under their control for their product.
Customers are welcome to perform an audit on-site. Depending on the audit frequency and the size of your business with us, we might need to charge for an audit.
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 we can add value due to our experience to your QMS or technical file, we can offer a consulting service. Examples are risk management, a literature search for biocompatibility testing, and a review of certain parts of the technical file.