Rimsys
Rimsys offers a unified Regulatory Information Management (RIM) platform purpose-built for MedTech teams. Automate regulatory processes, centralize data, and accelerate time-to-market with their cloud-based solution.
Rimsys provides a holistic RIM software solution designed to digitize and automate regulatory activities for MedTech companies. Their platform centralizes all regulatory information, including registrations, certificates, submission documents, and UDI data, creating a single source of truth. This helps regulatory affairs teams work more efficiently, reduce compliance risks, and bring products to market faster. The Rimsys platform is specifically built to address the complexities of global regulatory compliance, including EUDAMED. It offers purpose-built tools and expert guidance to streamline data collection, verification, and submission processes. By automating workflows and providing real-time alerts, Rimsys empowers companies to manage product registrations, selling status, and the impact of regulatory changes with confidence. With a focus on security and privacy, Rimsys ensures data is protected through encryption, role-based access controls, and regular audits. Their flexible, cloud-based pricing model scales with customer success, making advanced regulatory management accessible to teams of all sizes.
About
**Who they are**
Rimsys offers a unified Regulatory Information Management (RIM) platform purpose-built for MedTech teams, aiming to automate regulatory processes and centralize data.
**Expertise & scope**
* Cloud-based platform for regulatory activities, scaling with team size.
* Specializes in EUDAMED compliance, assisting with UDI data collection and structuring.
* Provides tools for automated verification, transformation workflows, and pre-configured submission processes for EUDAMED.
* Offers access to internal experts involved in MedTech Europe UDI and EUDAMED working groups.
* Supports unified data management across all regulatory activities.
**Reputation / proof points**
* Trusted by large medtech companies.
* Follows international standards and industry best practices for data security.
* Undergoes annual SOC 2 Type 2 audits and triennial ISO 27001 audits by third-party assessors.
Rimsys offers a unified Regulatory Information Management (RIM) platform purpose-built for MedTech teams, aiming to automate regulatory processes and centralize data.
**Expertise & scope**
* Cloud-based platform for regulatory activities, scaling with team size.
* Specializes in EUDAMED compliance, assisting with UDI data collection and structuring.
* Provides tools for automated verification, transformation workflows, and pre-configured submission processes for EUDAMED.
* Offers access to internal experts involved in MedTech Europe UDI and EUDAMED working groups.
* Supports unified data management across all regulatory activities.
**Reputation / proof points**
* Trusted by large medtech companies.
* Follows international standards and industry best practices for data security.
* Undergoes annual SOC 2 Type 2 audits and triennial ISO 27001 audits by third-party assessors.
Additional information
Rimsys's platform is designed for MedTech companies facing the complexities of EUDAMED compliance. They offer a free spreadsheet template to help structure UDI data, a critical first step for many. The platform aims to streamline the process of collecting, verifying, and submitting data, reducing the manual effort required. Buyers should note that Rimsys emphasizes a unified approach to regulatory information management, integrating various compliance activities into a single system. Their security features include SSO, role-based access controls, audit logging, and data encryption, with privacy policies aligned with GDPR and CCPA.
Key Highlights
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Offers a unified Regulatory Information Management (RIM) platform for MedTech teams.
Source
“Rimsys offers a unified Regulatory Information Management (RIM) platform purpose-built for MedTech teams.”
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Provides tools and guidance specifically for EUDAMED compliance.
Source
“The Only Unified RIM System for EUDAMED Compliance”
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Employs robust security measures including data encryption, SSO, and role-based access controls.
Source
“Data encryption: 100% of data is encrypted at transit and at rest.”
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Undergoes annual SOC 2 Type 2 audits and triennial ISO 27001 audits.
Source
“We undergo a SOC 2 Type 2 audit annually and an ISO 27001 audit every three years by third-party assessors.”
Certifications & Trust Signals
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Trusted by some of the world’s largest medtech companies.
Source
“We’ve built industry-leading security into every aspect of our business, and are trusted by some of the world’s largest medtech companies.”
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Platform is 100% cloud-based with flexible pricing not tied to individual user seats.
Source
“100% cloud-based”
Buyer Snapshot
Best for
- MedTech companies seeking to automate regulatory processes.
- Organizations needing to achieve EUDAMED compliance.
- Teams requiring a centralized platform for regulatory information management.
How engagement typically works
- Cloud-based platform subscription.
- Access to expert guidance for EUDAMED compliance.
Typical deliverables
- Unified RIM platform access.
- EUDAMED compliance tools and workflows.
- Structured UDI data collection templates.
- Automated verification and submission processes.
Good to know
- Best when integrated into existing regulatory workflows for maximum efficiency.
Pricing
Model:
Custom pricing
HQ:
US
Languages:
English
Status:
listed
Services & Capabilities
EUDAMED M2M Integration
Pricing model:
Custom pricing
Supported Modules:
UDI/Devices, Certificates
Provides Access Point:
Yes
Additional eudamed_m2m Details
Supported Modules
UDI/Devices, potentially others related to submissions and product registrations.
