What we do
Versatile Enterprise Suite
From FDA submissions to recall readiness—RP360 delivers the structure, automation, and audit trails your teams need to stay inspection-ready.
Lower Operational Risk
Identify issues before they escalate with proactive monitoring and alerts.
Compliance Workflows
Adapt forms and approvals to ISO 13485, GDPR, or FDA 21 CFR Part 11 standards.
Role-Based Data Control
Assign field-level permissions and granular access for legal, QA, and engineering teams.
Secure & Scalable
Built on enterprise-grade infrastructure with support for MFA, SSO, and tenant-level security.
Compliance Without Complexity
Form Builder with Inheritance
Create reusable, drag-and-drop forms with dynamic logic and audit-traceable changes.
Risk Scoring & Recall Prediction
Evaluate product risk with configurable scoring models and early recall detection tools.
Regulatory File Automation
Generate, manage, and track FDA-ready documentation in structured formats.
Data Import & Mapping Tools
Seamlessly upload, map, and validate large datasets (CSV/XLS) across workflows.
Audit Logs & Activity History
Every action is logged for compliance transparency and role-based visibility.
Soft Delete & Trash Management
Recover deleted records with context—by form, data type, or module.
Designed to Eliminate Gaps Across Teams & Systems
Whether you're preparing for audit, launching a new device, or managing CAPA workflows, RP360 connects the dots.
Where Legacy Systems Fall Short
Connected Data Layers
Sync risk scores, quality issues, and compliance forms for a 360° view of your operations.
Real-Time Collaboration
Assign tasks, track progress, and maintain full auditability across departments.
Secure Vendor & Partner Access
Grant controlled, scoped access to third-party vendors for co-managed workflows.
Trusted by Medical Device Leaders, Built for High-Stakes Roles
Class II Device Manufacturers
Regulatory Affairs Teams
Quality Management Systems
Legal Risk Teams
ISO/GxP-Focused Organizations
Let's Talk About
What's Possible
Whether you're seeking a strategic advantage or a trusted partner, the RP360 team is here to connect.
Why Choose RP360?
- Enterprise-Grade Control
- Precision-Driven Framework
- Configurable, Secure & Scalable
- Live Support & Success Team
What happens next?
1
We schedule a call when you're free
2
We hold a discovery and consulting meeting
3
We prepare and deliver a custom proposal