Rimsys Platform pricing
Digitize and automate all of your regulatory activities in a single platform with flexible pricing that scales with your success
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We believe that truly centralized information and broad collaboration are key to efficient and effective regulatory affairs. That’s why we developed a holistic platform that organizes all of your regulatory information at the individual product level and a pricing model that isn’t tied to individual user seats.
Complete, product-centric platform
- Registrations
- Submissions
- UDI
- Essential Principles
- Standards Management
- Regulatory Intelligence
Scalable cloud architecture
- 100% cloud-based
- Nothing to install and maintain
- Hosting options in the US or EU
- Supports teams of any size
Comprehensive data privacy and security
- SOC-2 Type 2
- ISO-27001
- GDPR
What’s included
Core capabilities
Detailed product information (part number, UDI, product hierarchy)
Customizable workflow and approval structure
Email and in-app notifications
Task assignment and tracking
Customizable self-service reporting
Collaboration with internal and external teams
Notes with automatic association (project, registration, etc.)
Roles and permissions-based accounts for unlimited users
Enterprise integrations with ERP/PLM/QMS
Federated SSO Capable Authentication (SAML 2.0, OAuth)
Product registrations
Registration tracking and certificate management
Submission planning and requirements
In-app document creation and editing
SKU-level management
Project workflow (kanban board, owners, target dates, reports)
Sales status control
Account management (in-country sponsors, notified bodies, and more)
Project task management
Regulatory submissions
Country market entrance requirements
Government-specific templates (STED, CSTD, 510k, and more)
In-app document creation and editing
Rich text, collaborative content authoring
Auto-generation of submission table of contents and appendices
Reusable snippets, cover letters, and company letterheads
Correspondence tracking with health agencies
Automated approval routing
PDF publishing/generation of submission packages
Searchable submission history
Essential principles/GSPR
Templates for EU MDR/IVDR, Australia, Brazil, China, and more
Custom template creation
In-app document creation, editing, and signature approval
Standards linking with automatic change notifications
Compliance evidence integration with external systems
Approvals workflow and routing
Document version control
Searchable PDF record generation
Embeddable documents within PDF
Bulk updates: add, replace, approve, signature routing, and more
Standards management
Customizable standards library
Standards association at the product level
Access to 200+ Standards Development Organizations (SDOs)
Change notifications
UDI
Automated UDI updates as product registrations change
ADD-ON
EUDAMED, GUDID, and ROW compliant
ADD-ON
Electronic GUDID and EUDAMED* submissions (*coming soon)
ADD-ON
Integration with PLM, ERP, and labeling systems
ADD-ON
Security and privacy
Fully validated to ISO 13485:2016 requirements
21 CFR Part 11 compliant (electronic storage, e-signatures, audit logs)
GxP compliant infrastructure
ISO 27001 certified ISMS and SOC2 Type 2 compliant
Support
24/7 technical support
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