Product Requirements Captured and Monitored
To master product complexity it is vital to capture all the functional and technical requirements of a new product or the revised version of an existing product. Monitoring these requirements over the course of the development process will ensure that the final product will fulfill these requirements when establishing product compliance dossiers for submission.
Through its requirements management capabilities the 3DEXPERIENCE platform becomes an enabler for the transformation of the overall development process, facilitating a measurable, value based assessment of product functions and capabilities and a true systems engineering approach for medical devices.
FDA Compliance Streamlined
Regulatory compliance for medical devices is defined in the Food and Drug Administration’s (FDA) 21CFR Part 820. It not only defines what needs to be submitted to the FDA for the application of market authorization, the 510(k), but also specifies all the data, information, and events that need to be captured over the course of the product development cycle.
Through its powerful concept of data and business process integration the 3DEXPERIENCE platform provides comprehensive data management and application functionality to manage the product compliance in a holistic way and to effectively manage key elements of FDA compliance such as
- Design History File (DHF)
- Device Master Record (DMR)
- Device History Record (DHR)
The integrated change management on the platform always makes sure to link the right versions of requirements, documents and compliance deliverables together in a consistent and auditable manner.
Fully Integrated Product Quality Management
Quality management and control for medical devices is essential to ensuring patient safety and meeting customer and market expectations. 3DEXPERIENCE enables a quality management process that is rooted in the Total Quality Management (TQM) approach and allows to manage and execute Corrective Action Preventive Action (CAPA) processes and Non Conformance Reports (NCR), yet again in its fully integrated environment.
