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 offers a unified Regulatory Information Management (RIM) platform purpose-built for the medical technology industry, founded in 2017 by regulatory affairs professionals. They aim to digitize, automate, and create regulatory order for MedTech companies.

**Expertise & scope**
* Digitizing and automating regulatory activities in a single platform.
* Managing global product registrations, standards, and selling status.
* Addressing challenges related to EUDAMED compliance, including UDI data collection and submission.
* Providing a platform designed to increase RA productivity, manage complexity, and reduce compliance risks.
* Offering solutions for MedTech firms facing scattered, incomplete, or missing UDI data.

**Reputation / proof points**
* Founded in 2017.
* Platform is 100% cloud-based with hosting options in the US or EU.
* Supports teams of any size.
* 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

  • Offers a unified Regulatory Information Management (RIM) platform purpose-built for MedTech. Source
    “The Rimsys Platform is designed specifically to help medtech companies address these challenges, and confidently establish global regulatory compliance.”
  • Digitizes and automates regulatory activities to accelerate market entry and reduce compliance risks. Source
    “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.”
  • Provides specific tools and guidance for EUDAMED compliance, including UDI data management. Source
    “Purpose-Built Tools and Expert Guidance”
  • Platform is 100% cloud-based with flexible pricing not tied to individual user seats. Source
    “100% cloud-based 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.”

Certifications & Trust Signals

  • Founded in 2017 by regulatory affairs professionals. Source
    “Rimsys was founded in 2017 by regulatory affairs professionals who asked the simple question: “Isn’t there a better way to do this?””
  • Platform is SOC-2 Type 2 certified. Source
    “SOC-2 Type 2”

Buyer Snapshot

Best for
  • MedTech companies seeking to digitize and automate regulatory affairs.
  • Organizations needing to manage global product registrations and compliance.
  • Firms preparing for EUDAMED compliance and UDI data submission.
How engagement typically works
  • Platform-based solution for regulatory information management.
  • Focus on automation and centralized data.
Typical deliverables
  • Unified Regulatory Information Management (RIM) platform access.
  • Digitized and automated regulatory workflows.
  • Tools for UDI data collection and EUDAMED submission.
  • Centralized product registration information.
Good to know
  • Best when a unified, cloud-based approach to regulatory management is desired.

Pricing

Model: Usage-based
HQ: New York, US
Languages: English
Timezones: America/New_York
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
Utilize free spreadsheet template to collect and structure UDI data; Automated verification and transformation workflows; Pre-configured submission process requiring minimal input; Access to internal experts.
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
Supports Actor Registration
Implied through EUDAMED compliance services.
Supports UDI
Yes
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