Medical Device Regulation (MDR) and versatility at the heart of the conception
Today, Medical Device Regulation (MDR) has become a major point of concern for all contact lenses manufacturers. Therefore, not only a metrology tool must be reliable and performant, it also requires a high level of data safety and traceability. Lambda-X perfectly integrated this new framework imposed to our industry and deeply blended the MDR directives into the development of the new CLE-MENTOR software.
Safety & traceability. The core of CLE-MENTOR is its database which ensures a very high level of data safety by prohibiting any modification of the measurement results. The advanced user management capabilities – allowing the definition of individual credentials ranging from full control and access to high level of restriction – along with a full audit log, warranties complete traceability of your data. These essential assets linked to many functionalities such as the lockable measurement templates or the automatic generation of reports (to name just a few) make the application directly compliant with FDA’s 21 CFR part 11 guidelines.
Versatility and Adaptability. Assessing today’s contact lens manufacturing landscape, we must acknowledge a wide variety of needs expressed by manufacturers. These needs greatly depend on the level of automation of the lab, hence, on the production volume. R&D, Specialty Labs or Mass production involves very different demands for lens characterization and data management. Consequently, we have designed CLE-MENTOR with three different workflows, each of them optimized to provide the best experience to each user profile. Fully ready for integration into automated production environments, it can be operated manually by operators, through a simple QR/barcode scan or controlled remotely without human interaction.
You need more or different? The advanced API – Application Programming Interface – of CLE-MENTOR makes the application extremely versatile, fully customizable and ready for production environments ranging from fully manual specialty labs operation to highly automated moulding plants. You need a centralized database, an integration with your ERP – such as FOCAL POINT – no problem – CLE-MENTOR is ready for that!
You have full control, you decide!