Balance quality and compliance in medical device manufacturing

Medical device manufacturers face challenges in ensuring both high product quality and regulatory compliance due to evolving guidelines, varying employee engagement and information overload. Balancing quality and compliance is tricky, given limited resources and budget constraints. Our Closed Loop Quality and Compliance tools provide an integrated digital backbone, a comprehensive Quality Management System (QMS) and an innovative Regulatory Information Management System (RIMS) to harmonize quality and compliance efforts throughout the device lifecycle.

Read our ebook to learn more.

Ensure process efficiency with a comprehensive QMS

Our Quality Management System (QMS) tools aid medical device manufacturers in ensuring quality process efficiency and compliance validation. These tools provide full traceability of design development phases, facilitating a comprehensive Design History File/Device Manufacturing Record (DHF/DMR) and smooth design transfer to production.

Establish information transparency

A unique Regulatory Information Management System (RIMS) allows manufacturers to maintain a clear view of context and regulatory compliance throughout the entire product and market lifecycle. This customizable system, based on low-code apps, fosters collaboration among different regulatory affairs teams by providing easy access to a unified repository of information. It ensures integrated data management, connecting with existing systems and aligning with evolving company processes across all lifecycle phases, from design control and transfer to production and post-market surveillance.

Read our ebook to learn how Closed Loop Quality and Compliance enhances organizational compliance and continuously acts on medical device quality.