OptiScan systems enable real-time, in vivo imaging at the cellular level in human and animal tissue and they are applicable to a growing and exciting range of applications.
Currently OptiScan has a collaboration arrangement with Carl Zeiss Meditec. The company is currently working on trials and research in relation to breast cancer and is investigating additional clinical applications.
If you, your organisation or company, are interested in exploring opportunities to use OptiScan systems for new areas of research or clinical applications, we would welcome the opportunity to discuss them with you.
Design and manufacturing to regulatory standards
OptiScan have the expertise and processes required to design, develop and manufacture products for regulated markets. Satisfying international standards for complex development projects in both clinical and pre-clinical applications, we have helped our partners obtain regulatory approvals including FDA 510(k) and CE Mark and assisted in Clinical Trial Submissions (Australia (CTN), US (IDE) and EU) by incorporating the requirements of the following standards into our processes and quality systems.
- ISO 13485 (Medical devices – Quality management systems)
- ISO 14971 (Risk management of medical devices)
- IEC 62304 (Medical device software – Software life cycle processes)
- IEC 60601 (Safety for Medical Electrical Equipment)
- IEC 61010 & IEC61326 (Electrical Safety and EMC for Laboratory Electrical Equipment)
- IEC 60825 (Safety of Laser Products)
- ISO 14155 (Clinical Investigations)
- ISO 10993 (Biocompatibility)
- ISO 10110 (Optics and Photonics)
Experience, expertise and technical resources
The combination of OptiScan’s highly skilled staff and state of the art equipment and facilities provide strong capabilities in all factors of the product development cycle, including;
- Engineering Design for Manufacture (optical, electrical and mechanical and software)
- Prototype construction
- Engineering design verification
- All devices and assemblies are built within our in-house manufacturing facilities (including ISO Class 9 Cleanroom and environmental monitoring
- Component procurement and supplier management from sources around the world