Rimsys
Rimsys offers a unified Regulatory Information Management (RIM) platform purpose-built for MedTech, digitizing and automating regulatory activities to accelerate market entry and reduce compliance risks.
Rimsys provides a holistic RIM software solution designed specifically for the MedTech industry, aiming to digitize and automate all regulatory activities within a single, cloud-based platform. Their solution helps regulatory affairs teams enhance efficiency, reduce compliance risks, and expedite product launches by centralizing regulatory information, managing workflows, and automating processes. The platform supports the creation and management of a single source of truth for registrations, certificates, submission documents, technical files, UDI, and correspondence with health authorities, ensuring consistent and up-to-date information across the organization. Rimsys is particularly focused on addressing the complexities of global regulatory landscapes, including EUDAMED compliance, by offering tools for UDI data management, automated verification, and pre-configured submission processes, backed by expert guidance.
About
**Who they are**
Rimsys is a regulatory information management platform provider founded in 2017 by regulatory affairs professionals to address the complexities of the medical technology industry. They aim to digitize and automate regulatory activities, reducing compliance risks and accelerating market entry.
**Expertise & scope**
* Unified Regulatory Information Management (RIM) platform purpose-built for MedTech.
* Digitizes and automates regulatory activities, including product registrations, submissions, and standards management.
* Specializes in EUDAMED compliance, offering tools and guidance to facilitate data posting and regulatory adherence.
* Supports UDI data collection, verification, and transformation workflows.
* Provides a cloud-based platform with flexible pricing not tied to individual user seats.
**Reputation / proof points**
* Founded in 2017.
* Offers a 100% cloud-based platform with hosting options in the US or EU.
* Platform is SOC-2 Type 2 certified.
Rimsys is a regulatory information management platform provider founded in 2017 by regulatory affairs professionals to address the complexities of the medical technology industry. They aim to digitize and automate regulatory activities, reducing compliance risks and accelerating market entry.
**Expertise & scope**
* Unified Regulatory Information Management (RIM) platform purpose-built for MedTech.
* Digitizes and automates regulatory activities, including product registrations, submissions, and standards management.
* Specializes in EUDAMED compliance, offering tools and guidance to facilitate data posting and regulatory adherence.
* Supports UDI data collection, verification, and transformation workflows.
* Provides a cloud-based platform with flexible pricing not tied to individual user seats.
**Reputation / proof points**
* Founded in 2017.
* Offers a 100% cloud-based platform with hosting options in the US or EU.
* Platform is SOC-2 Type 2 certified.
Additional information
Rimsys offers a free spreadsheet template to help MedTech firms collect and structure UDI data for electronic EUDAMED submission. This template indicates required and optional fields and includes built-in dropdowns for data consistency. The platform features automated verification and transformation workflows, a pre-configured submission process, and access to internal experts who are members of MedTech Europe UDI and EUDAMED working groups. They emphasize unified data management across all regulatory activities to streamline compliance.
Key Highlights
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Offers a unified Regulatory Information Management (RIM) platform purpose-built for MedTech.
Source
“The Only Unified RIM System for EUDAMED Compliance”
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Digitizes and automates regulatory activities to accelerate market entry and reduce compliance risks.
Source
“digitize, automate, and create regulatory order for the medical technology industry.”
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Provides tools and guidance to facilitate EUDAMED compliance, including UDI data management.
Source
“Rimsys Gets You to EUDAMED Compliance Faster”
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Cloud-based platform with flexible pricing not tied to individual user seats.
Source
“a pricing model that isn’t tied to individual user seats.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- MedTech companies seeking to digitize and automate regulatory affairs.
- Organizations needing to streamline EUDAMED compliance and UDI data management.
How engagement typically works
- Platform-based solution with expert guidance.
- Focus on automation and centralized data management.
Typical deliverables
- Unified RIM platform access.
- Automated verification and transformation workflows for UDI data.
- Support for product registrations and regulatory submissions.
- Guidance for EUDAMED compliance.
Good to know
- Best when organizations are looking for a scalable, cloud-based solution to manage regulatory complexity.
Pricing
Model:
Usage-based
HQ:
New York, US
Languages:
English
Timezones:
America/New_York
Claim status:
Listed
Services & Capabilities
Best EUDAMED Registration| Compare & Get Quotes
Jurisdictions:
EU
Countries:
SE, IE, PL, NL, DK, IT, DE
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
26-100
Onboarding time:
3–21 days
Pricing model:
Usage-based
Starting from:
USD 1,500
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Actor/SRN, UDI/Devices
Supports Training Enablement:
Yes
Data Load Support Level:
Done-for-you
Turnaround SLA:
Custom
eifu_platform
Additional eudamed_reg_support Details
Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
Offers a free spreadsheet template to collect and structure UDI data; provides guidance for EUDAMED readiness.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
UDI/Devices, potentially others related to submissions and registrations
Supports Actor Registration
Implied through EUDAMED compliance support
Supports UDI
Yes, explicitly mentioned for data collection, verification, and transformation.
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