One of the first steps on the road to clinical products is the selection of Materials and Suppliers. It does not matter for Vosfox Medical if you do not know which material you want to use or if the material and supplier are already fixed. We can support you with the following services.
Material Selection
You have a design and even made some samples, but the final choice for materials has not been made. We can help you with material selection, depending on the requirements and application of your device or component. We can perform or organise tests to confirm the suitability of the chosen material. Of course, we can also suggest a supplier.
Supplier Selection and Qualification
Maybe you already know which material you want to use. You did already done several trials with this material. However, up to now, you used a technical or laboratory-grade of materials. This might not be the correct quality for your application, or the supplier cannot fulfil the regulatory and quality requirements (like change control). We can find a supplier for you.
All critical suppliers must be qualified. We will collect the required information on the product and the supplier, such as technical and safety datasheets, ISO certificates, REACH or other declarations. For critical products and subcontractors, we will have a quality assurance agreement (QAA) with the supplier, and we can perform supplier audits.
Monitoring
The monitoring of suppliers is an integral part of the quality system. Monitoring activities depend on the risk, the product’s criticality, and the supplier’s performance in the previous period. Monitoring can be done by reviewing and scoring the supplier’s performance, sending questionnaires or doing an audit on-site.