The validation of any production process is about being in control of that process. In manufacturing with 3D printers, controlling the complete production process can be a tricky and time consuming job. A clear view of what is required and a step by step approach can help manage the validation process. This presentation will include a rough overview of what is involved in 3D printer validation by discussing an example.
A presentation by Sandra de Vos, CEO / Founder at Vosfox Medical.
As CEO of Vosfox Medical, I am responsible for the quality of the medical devices we make. We have an ISO13485 certificate and ISO class 7 cleanroom. Our challenge is to fulfil all requirements and optimize our workflow to keep the qualification costs low for our customers. We can support our customers in process development/optimization, risk analysis, process, packaging, or sterilization validation. Vosfox specialises in small scale production for the medical device market (3D printing, moulding, assembly, mixing etc.)
About Vosfox Medical
Vosfox Medical supports companies in bringing their medical devices to market quickly and efficiently. We accomplish this by offering small-scale production facilities to assist with/perform the production process development and validate processes. Simultaneously, we can carry out packing and label development and set up packaging and sterilisation validation. Apart from the complete production line aspects, from raw materials to fully packaged medical devices, we also provide QA / RA support.
Sandra de Vos is speaker at the 2022 edition of the 3D Medtech Printing Conference.