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 provides a unified Regulatory Information Management (RIM) platform designed for MedTech teams, offering a cloud-based solution to automate regulatory processes and centralize data.
**Expertise & scope**
* Unified platform for all regulatory activities, organizing information at the individual product level.
* Specializes in EUDAMED compliance, offering tools and guidance to accelerate data posting and meet requirements.
* Supports UDI data collection, verification, and transformation workflows for EUDAMED submissions.
* Provides access to internal experts involved in MedTech Europe UDI and EUDAMED working groups.
* Offers a comprehensive RIM system purpose-built for EUDAMED compliance.
**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 provides a unified Regulatory Information Management (RIM) platform designed for MedTech teams, offering a cloud-based solution to automate regulatory processes and centralize data.
**Expertise & scope**
* Unified platform for all regulatory activities, organizing information at the individual product level.
* Specializes in EUDAMED compliance, offering tools and guidance to accelerate data posting and meet requirements.
* Supports UDI data collection, verification, and transformation workflows for EUDAMED submissions.
* Provides access to internal experts involved in MedTech Europe UDI and EUDAMED working groups.
* Offers a comprehensive RIM system purpose-built for EUDAMED compliance.
**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 built with security and data privacy as primary considerations, adhering to GDPR and CCPA regulations. They implement robust security features including SSO via OAuth 2.0 with 2FA support, role-based access controls, comprehensive audit logging, and session control via unique bearer tokens. All data is encrypted in transit and at rest, with client communications enforced through HTTPS. Customer data is logically segregated and stored separately, with regular backups and replicated database instances for fail-over. Their pricing model is flexible and scales with client success, not tied to individual user seats, supporting teams of any size.
Key Highlights
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Offers a unified Regulatory Information Management (RIM) platform purpose-built 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 expert guidance to accelerate EUDAMED compliance.
Source
“Purpose-Built Tools and Expert Guidance”
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Automates regulatory processes and centralizes data with a cloud-based solution.
Source
“Automate regulatory processes, centralize data, and accelerate time-to-market with their cloud-based solution.”
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Pricing is flexible and scales with success, not based on individual user seats.
Source
“a pricing model that isn’t tied to individual user seats.”
Certifications & Trust Signals
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Undergoes annual SOC 2 Type 2 audits.
Source
“We undergo a SOC 2 Type 2 audit annually”
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Conducts triennial ISO 27001 audits by third-party assessors.
Source
“and an ISO 27001 audit every three years by third-party assessors.”
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Data is 100% encrypted in transit and at rest.
Source
“100% of data is encrypted at transit and at rest.”
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Supports SSO via OAuth 2.0 and 2FA.
Source
“SSO via OAuth 2.0: Sign in through your preferred identity vendor (OKTA, Azure Active Directory, etc.), and support 2FA.”
Buyer Snapshot
Best for
- MedTech companies seeking to streamline regulatory processes.
- Organizations needing to achieve EUDAMED compliance efficiently.
- Teams requiring a centralized platform for regulatory information management.
How engagement typically works
- Cloud-based platform subscription.
- Access to expert guidance and resources.
Typical deliverables
- Automated regulatory process workflows.
- Centralized regulatory data management.
- EUDAMED submission readiness.
- UDI data structuring and verification tools.
Good to know
- Best when integrated into a broader regulatory strategy.
Pricing
Model:
Custom pricing
HQ:
US
Languages:
English
Claim 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, Actor (implied for EUDAMED compliance)
