Streamline Production and Improve Quality Processes

From reagents to instruments to systems intended for use, document your design controls, build your hierarchies of components and subcomponents, and manage your product families. Streamline and automate the management of reports, matrices, and other documentation needed to develop your product and ensure regulatory compliance.

Identify, mitigate, and prevent potential risks early and often. Integrate risk management beyond your design. Proactively find and fix issues that expose you to risk throughout the product lifecycle.

An IVD is subject to the same pre- and post-market controls as a medical device. It requires a quality system and similar risk-based classification. With so many changes to the new, stringent regulations of IVDR, it’s essential to understand how to be compliant and have the solutions to do so. Let us help you simplify compliance so you can focus on building high-quality products.

Simplify and stay on top of all post market quality activities and processes for monitoring and measurement of output, data analysis, and product improvement. Maintain a holistic view of the lifecycle of your product throughout all areas of your system.

Enhance team access to cross functional data and drive accountability by managing device requirements and quality efforts in a centralized workspace. Keep your teams aligned with the latest information, facilitate team communication, and streamline approvals using flexible review workflows with both internal and external stakeholders.