Reduce The Complexity of Combination Product Development

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.

Combination products are inherently complex. Identify, mitigate, and prevent potential risks early and often. Integrate risk management to your product development. Proactively find and fix issues that expose you to risk throughout the product lifecycle.

De Novo, 510(k), Premarket approval, CE markings, technical files—the list is never-ending. With governing authorities still developing their own regulatory processes, manufacturers have new opportunities to shape the present and future landscape. At the same time, companies developing combination medical technologies can control the unknowns and reduce barriers to compliance with our purpose-built QMS software that functions beyond general-purpose tools.

Simplify and stay on top of all postmarket 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.