Regulatory Project Management & Tracking

for Medical Devices

Accelerate Compliance and Innovation with AI-Driven Project Management

In today’s fast-paced Medical Device / Diagnostic landscape, staying compliant with evolving global regulatory requirements is more demanding than ever. Medical device companies must juggle complex submissions, documentation cycles, and multi-market launches – often across jurisdictions like FDA (U.S.), MDR (EU), and ISO 13485 (global).

DDi’s AI-enabled regulatory project management platform empowers medical device companies to streamline compliance, reduce errors, and bring products to market faster – all while staying audit-ready.

The Problem: Regulatory Complexity, Manual Burden

Traditional project management approaches rely heavily on manual tracking, spreadsheets, emails, and disconnected systems – introducing major limitations:

Human errors in document versioning or submission timelines
Delays in approvals due to inefficient workflows
Lack of real-time visibility for project stakeholders
Difficulty adapting to changing global regulations

These gaps can slow down product launches and increase compliance risks.

How DDi Modernizes Regulatory Project Management with AI

Our intelligent regulatory management platform is designed specifically for medical device companies, combining automation, predictive analytics, and compliance insight to optimize every stage of your regulatory journey.

Intelligent Document Automation

AI-powered tools scan, extract, tag, and validate regulatory documents (e.g., STED, CERs, labeling, technical files) with unmatched speed and consistency.

Auto-tagging, classification, and version control
NLP-based formatting and validation
Alignment with FDA, MDR, and ISO 13485 templates

Predictive Risk Forecasting

Our system learns from past submissions to highlight potential delays, bottlenecks, or missing elements – before they become roadblocks.

Approval timeline prediction
Workflow risk alerts
Inconsistency detection in submission packets

Workflow Automation & Deadline Tracking

Streamline regulatory workflows with Robotic Process Automation (RPA). From form-filling to stakeholder alerts, DDi ensures every deadline is tracked and met.

Smart milestone calendars
Auto-reminders and escalation triggers
Submission status dashboards

Real-Time Global Regulatory Intelligence

Monitor and adapt to ongoing changes in regulatory policies worldwide.

Real-time updates from FDA, EU MDR, PMDA
Dynamic compliance checklists
Localized submission strategies for multi-region launches

Built-In Audit Readiness

Maintain a complete audit trail, document history, and traceability logs to ensure you’re always prepared for inspections.

Export-ready reports
Role-based access controls
Change logs with version traceability

Benefits of Using DDi for Medical Device RPM

Faster Approvals: Predictive workflows and automation reduce delays
Improved Accuracy: Minimize manual errors and rework
Scalable Compliance: Manage global projects from a unified platform
Always Audit-Ready: Ensure clean documentation trails and version control
Data-Driven Decisions: Gain actionable insights into risks and performance

Future-Proof with AI-Driven Compliance

Tomorrow’s Medical Device / Diagnostic innovators will need more than spreadsheets to stay competitive. With AI-enabled regulatory management, expect to see:

Adaptive AI that learns from each submission
Voice-activated compliance tools
Instant alerts for regulation changes
AI-led response simulations for regulatory authority expectations

With DDi, the future is already here.

Ready to Revolutionize Your Regulatory Workflows?

Whether launching a Class I device or navigating EU MDR, DDi’s platform ensures smarter, faster, and more compliant regulatory execution.

Book a Demo or connect with our Medical Device Automation experts today

Related Tools & Solutions

Regulatory Project Management & Tracking

for Medical Devices

Accelerate Compliance and Innovation with AI-Driven Project Management

The Problem: Regulatory Complexity, Manual Burden