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 designed for MedTech teams, providing a cloud-based solution to automate regulatory processes and centralize data.
**Expertise & scope**
* Unified RIM platform purpose-built for MedTech
* Automates regulatory processes and centralizes data
* Accelerates time-to-market with a cloud-based solution
* Specializes in EUDAMED compliance, assisting with UDI data collection and submission workflows
* Provides tools for product registrations, regulatory submissions, essential principles/GSPR, and standards management
**Reputation / proof points**
* Trusted by some of the world's largest 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 designed for MedTech teams, providing a cloud-based solution to automate regulatory processes and centralize data.
**Expertise & scope**
* Unified RIM platform purpose-built for MedTech
* Automates regulatory processes and centralizes data
* Accelerates time-to-market with a cloud-based solution
* Specializes in EUDAMED compliance, assisting with UDI data collection and submission workflows
* Provides tools for product registrations, regulatory submissions, essential principles/GSPR, and standards management
**Reputation / proof points**
* Trusted by some of the world's largest 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 focuses on streamlining EUDAMED compliance by offering a unified RIM system. They provide tools to collect and structure UDI data, including a free spreadsheet template. Their platform features automated verification and transformation workflows, along with pre-configured submission processes. Clients benefit from access to internal experts who are active in MedTech Europe UDI and EUDAMED working groups. The platform supports unified data management across all regulatory activities, aiming to simplify the path to EUDAMED readiness.
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 guidance to accelerate EUDAMED compliance, including UDI data structuring.
Source
“Collect your UDI data and get your regulatory ducks in a row — and get started today with our free spreadsheet template.”
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Platform is 100% cloud-based with flexible pricing not tied to individual user seats.
Source
“100% cloud-based”
Certifications & Trust Signals
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Undergoes annual SOC 2 Type 2 audits and triennial ISO 27001 audits by third-party assessors.
Source
“We undergo a SOC 2 Type 2 audit annually and an ISO 27001 audit every three years by third-party assessors.”
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Implements robust security features including SSO, role-based access controls, and data encryption.
Source
“SSO via OAuth 2.0: Sign in through your preferred identity vendor (OKTA, Azure Active Directory, etc.), and support 2FA.”
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Data is encrypted in transit and at rest, with logical segregation of customer data.
Source
“100% of data is encrypted at transit and at rest. Customer data is logically segregated from each other and stored in separate AWS S3 buckets.”
Buyer Snapshot
Best for
- MedTech companies seeking to automate regulatory processes
- Organizations needing a unified platform for regulatory information management
- Companies preparing for EUDAMED compliance
How engagement typically works
- Cloud-based platform subscription
- Access to expert guidance
Typical deliverables
- Automated regulatory process workflows
- Centralized regulatory data repository
- EUDAMED submission support
- UDI data management tools
Good to know
- Best when a comprehensive RIM solution is desired for MedTech regulatory affairs.
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 by EUDAMED compliance focus)
