Integrated Modules for End-to-End Regulatory Excellence
Our integrated regulatory information management system is built around modular components that adapt to your organizational needs. Each module supports different stakeholders, from management and regulatory affairs to IT teams, ensuring smooth collaboration and information flow.
You can configure and combine the following modules based on your business priorities:
- Regulatory Planning & Tracking – Manage global submission timelines and approvals.
- Product Registration Management – Track product licenses, renewals, and variations.
- Document & Dossier Management
– Maintain compliant documentation for every market.
- Change Control & Lifecycle Management – Ensure consistent tracking of product and regulatory changes.
- Analytics & Reporting Dashboard – Gain visibility into KPIs and compliance performance.
This modular design allows your teams to start small and scale up as compliance needs evolve, maximizing ROI while minimizing disruption.
Optimized Regulatory Operations Platform for Medical Devices
DDi’s regulatory operations software helps device manufacturers address key challenges in global compliance, from initial registration to post-market surveillance.
By standardizing processes and automating documentation, our platform enables faster submissions, error reduction, and improved transparency across geographies.
With a user-friendly interface and built-in best practices, DDi’s regulatory operations platform empowers your teams to:
- Collaborate across departments with unified access
- Ensure version control and audit readiness
- Maintain traceability throughout the regulatory lifecycle
- Reduce risk of data loss or duplication
Tailored Solutions for Your Organization>
Every medical device company operates differently. That’s why DDi offers customized RIM implementations that align with your business structure, compliance priorities, and budget.
Whether you’re a startup bringing a device to market or a global enterprise managing multi-region approvals, our team works with you to tailor the regulatory information management system for maximum impact.
- Modular deployment for flexibility
- Cloud or hybrid hosting options
- Scalable architecture for global growth
- Ongoing regulatory and technical support
Why DDi Smart?
DDi Smart combines deep domain expertise in medical device regulatory affairs with advanced technology to deliver solutions that simplify compliance and accelerate market readiness.
By leveraging automation, analytics, and integration, we help organizations achieve:
- 60–70% efficiency improvement in regulatory operations
- Enhanced data accuracy and submission quality
- Reduced compliance risk and faster time to market
Partner with DDi to future-proof your regulatory strategy and stay compliant with global health authority requirements.
