Built for Global Compliance CURA™ Speaks the Language of Regulation

Regulatory complexity in MedTech continues to grow at an unprecedented pace. From FDA requirements in the United States to MDR in Europe and international frameworks such as IMDRF and NCIT, manufacturers are required to navigate a constantly evolving web of standards, documentation formats, and reporting expectations. Each jurisdiction has its own terminology, processes, and data structures, and most organizations must manage several of them simultaneously.

For many quality and regulatory teams, this results in repetitive work, manual data mapping, and the constant risk of inconsistencies. Reports need to be reformatted for each authority, terminology must be aligned, and compliance rules must be double-checked at every stage. The administrative burden consumes valuable time that could otherwise be invested in quality improvement and innovation.

CURA™ was created to eliminate this complexity and replace it with a unified, intelligent approach to compliance.

A Platform that Understands Regulation

As an AI-powered lifecycle management system, CURA™ is pre-aligned with major global regulatory frameworks. It understands the structure and terminology of compliance. Whether an organization is preparing a Periodic Safety Update Report for EUDAMED, submitting an adverse event notification to the FDA, or aligning complaint classifications with IMDRF codes, the platform ensures that every piece of data follows the correct standard.

Each report generated by CURA™ is structured, traceable, and ready for inspection. The platform automatically applies the right templates and vocabulary for each jurisdiction, reducing the risk of missing or misinterpreted information. This alignment allows MedTech manufacturers to demonstrate compliance with confidence, no matter where their devices are sold or monitored.

Automation That Simplifies Compliance

One of the most time-consuming aspects of regulatory management is the manual preparation of documentation. Teams often need to format reports, cross-reference data fields, and reconcile naming conventions to meet each regulator’s expectations. CURA™ removes these steps through intelligent automation.

The platform maps complaint data to standardized vocabularies, applies predefined reporting structures, and generates submission-ready files for global authorities. Instead of manually compiling or validating data, teams simply review and approve automated outputs. This not only reduces the chance of human error but also ensures that every submission meets international standards from the start.

Automation also enables faster response times. When an authority requests additional information or an updated report, CURA™ retrieves and formats the data automatically, minimizing delays and maintaining consistency across submissions.

Alignment That Builds Confidence

CURA™’s built-in compliance alignment goes beyond efficiency. It establishes a single source of truth for regulatory data. Every workflow, from complaint handling to post-market surveillance, follows the same logic and terminology across all modules. This consistency makes it easier to prepare for audits, conduct internal reviews, and collaborate with external partners.

By standardizing compliance data, CURA™ helps MedTech organizations stay ahead of audits and maintain regulatory confidence across regions. Reports, records, and dashboards are always structured, traceable, and ready for review, allowing teams to demonstrate full control over their processes.

Operational Efficiency and Measurable Impact

The impact of this approach extends beyond compliance accuracy. CURA™ significantly reduces time spent on reporting and documentation management. Manual workload is cut by up to 90 percent, complaint processing accelerates by 95 percent, and productivity increases by more than 3500 percent. These gains come from replacing repetitive administrative tasks with intelligent automation, enabling QA and RA teams to focus on strategy, analysis, and improvement.

The system also adapts effortlessly to organizational growth. As new products enter the market or existing devices expand into additional jurisdictions, CURA™ scales with them. Its modular architecture and jurisdiction-specific templates ensure that expansion does not add complexity. New compliance requirements can be integrated seamlessly, maintaining consistent data quality and reporting accuracy across all operations.