Our product design and development services provides our clients with a single point of accountability throughout the entire product realization process. Based on the foundation of ISO 9001 and 13485 and Medical Device MD-SAP certified manufacturing, our manufacturing team deliver flexibility, IVD expertise and quality products.
We have a great deal of experience in impacting the production of IVD instruments for global diagnostics companies including Topcon and Menarini Diagnostics. Our manufacturing processes, quality procedures, production tools, logistics systems, operator training and resource management are precisely customized to perform in the constraints of the IVD domain.
We provide a flexible set of manufacturing solutions for each step of the product lifecycle and any business case, from prototyping and small batch production, to pilot production lines and full-volume production.
Our manufacturing facilities in Tuscany, Italy are certified to ISO 9001:2015 and ISO 13485:2016.