Custom Array Development
Utilizing our in-house development and printing facilities, we work directly with our clinical partners in designing, developing and manufacturing multiplex products in accordance with customer’s specification. Each project is controlled and documented using a Design History File providing traceability and history for the development process. The Array Development program has four phases of development which provide a step by step process which lends to minimizing risk. As you consider Quansys as a partner, contact us for a proposal for your intended panel. Based on your specifications, we will draft a statement of work detailing technical design and development, timelines and pricing.
Instrumentation and Software
To support clinical customers, Quansys offers the Q-View Imager Pro along with the Q-View Software. The Q-View Imager Pro integrates with a high grade CCD camera and optics which provides quality images with optimal sensitivity and reproducibility. The Q-View Imager Pro also is amenable to automation integration with an automated deck. In order to provide periodic maintenance and quality control on the Imager, or to establish and evaluate IQ/OQ/PQ criteria, customers may utilize the Q-View Qualification Plate.
The Q-View Software is the user interface for the Q-View Imager Pro. The software captures images, auto-finds the spots, processes the image, and exports data in customized formats. The software also has the components necessary to aid in CFR Part 11 compliance.
Quansys is an ISO 9001:2008 and ISO 13485:2003 registered company and complies with cGMP. Products are designed, developed, and manufactured according to the procedures outlined in our Quality Management System. We work hand in hand with our customers providing components or product based on their own regulatory preference, whether it is a 510K submission or for use in a CLIA environment.
Following successful development, manufacturing takes place in our Production Department. The components of the kit are manufactured and quality controlled based on joint QC release criteria. They are labeled as components for further manufacture and shipped.
Case Studies within Clinical Applications
Applications in Clinical Diagnostics
- Infectious Disease
- Inflammatory conditions
- Heart Disease