Future Diagnostics Diagnostic Assay Development Services
Since 1997, Future Diagnostics has been a leading provider of diagnostic assay development services to the medical diagnostics and device industries. With expertise encompassing a wide array of disease areas and detection technologies, Future develops high-quality in vitro diagnostic (IVD) products for its multi-national customers.
With its integrated quality management system (QMS) and ISO standards, Future is a reliable and independent partner to the most respected and innovative biotechnology companies, quickly expanding the capabilities of their internal R&D in support of their efforts to bring novel diagnostic products to market.
Assay development services
Future Diagnostics offers assay development across many technologies for automated laboratory systems and point-of-care (POC) devices. From the company’s inception, we have proudly conducted our development operations and successfully completed over 120 assay projects. Future utilises its well-established and documented procedures to guide every development programme, and to ensure that every project meets the highest quality standards and complies with applicable regulations.
At Future Diagnostics, we view every assay development project as a partnership between Future and our customer, adhering to your guidelines and expectations. Future has the expertise to perform all phases of the assay development process, and our work for each phase must be reviewed before a project can be advanced to the next phase. Future Diagnostics will produce bench lots, lab lots, and validation lots, and upon successful completion and approval of an assay development project, will formally transfer the assay to our customer.
Facilities for diagnostic assay development
In order to accommodate an increasing demand for its services, Future Diagnostics has recently moved its operations to a new, state-of-the-art, research and development, manufacturing, and administrative headquarters in Wijchen, the Netherlands. With this move, we have achieved our goal of integrating operations into one building with significantly expanded capacity.
Quality system for diagnostic assay development
Future Diagnostics has built a quality management system (QMS) that meets the requirements of the international standards ISO 9001 and ISO 13485, as well as the quality system regulations of the FDA (CFR 820). Assays are produced in compliance with the European IVD Directive.
The QMS provides the framework of Future’s commitment to achieve its internal quality objectives, meet its customer expectations, and satisfy IVD regulatory requirements. In order to guarantee a system of continuous improvement, all processes at Future Diagnostics are monitored by internal and external audits and by measuring process indicators.
Our quality initiatives are further supported by an organisation that brings broad experience and first-hand knowledge of the latest measurement technologies. Future Diagnostics is committed to delivering this expertise for its clients in every project.