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Enhance device design traceability with a digitalization and data-centric approach

Manufacturers encounter challenges in guaranteeing the safety and effectiveness of medical device designs, primarily stemming from the fragmented nature of the design control process. This fragmentation, marked by disparate spreadsheets and tools, leads to isolated data and a traceability deficit, potentially jeopardizing compliance and fostering errors or inefficiencies.

Our Design Control tools offer a solution through comprehensive digitalization and a data-centric approach, enhancing traceability and connectivity across the design process.

Enable traceability and ensure design safety and effectiveness

Manufacturers can ensure regulatory compliance and product safety by enabling complete traceability from risk files and analysis to device requirements and testing. Our Design Control tools facilitate the breakdown of design elements, offering searchable data and reporting capabilities for auditability and enabling extensive reuse. This approach enhances data integrity and streamlines the design process, reducing costs and time while increasing compliance and maintaining data integrity. Ultimately, it empowers manufacturers to develop compliant devices efficiently, meeting regulatory safety standards and sustainability commitments.

Download the ebook to learn more about our Design Control tools and how they ensure design safety and effectiveness.