With the ever increasing regulatory requirements of the clinical and in-vitro diagnostics (IVD) industries, Seyonic works with original equipment manufacturers (OEM), with customers who may add value by validating their chemistry test kits on sensor controlled integrated liquid handling platforms. Customers, acting as a value added reseller, may configure our products to exactly fit their application.
Our customers can utilize our standard products from the BioPharma market, our custom design group and our partners ability to integrate virtually any peripheral needed to fully automate an application, realizing validated results, reduced costs and the ability to implement the latest Sensor Controlled Pipetting technologies.
In our business model, customers approach us with an application or design. We then help configure a system and quote the parts based on processes, labor, tooling and material costs. Once a system prototype is delivered, customers may run the chemistries for proof of concept and to fine tune their assays. Once the chemistries are running reliably, we may then ‘lock down’ the configuration and finished the required regulatory documentation for the platform. At this point, customers may start the required FDA validation work of Premarket Notification (PMN) or 510(k).