Rimsys Reviews & Product Details

Rimsys is a specialized Regulatory Information Management (RIM) software solution designed specifically for MedTech manufacturers, addressing the unique regulatory challenges faced by this industry. Unlike generic software or those tailored for pharmaceuticals, Rimsys offers a comprehensive platform that centralizes and automates the management of critical regulatory processes, including product registrations, submissions, standards, essential principles, and global Unique Device Identification (UDI) data. This focus on the MedTech sector ensures that users can achieve full compliance with EUDAMED and M2M Transmission requirements, streamlining their operations and enhancing regulatory efficiency. Rimsys helps regulatory affairs professionals, compliance teams, IT teams, and MedTech leaders get through regulatory faster to drive revenue. As regulations become more complex, these professionals require a robust solution that not only simplifies compliance but also integrates seamlessly into their existing workflows. Rimsys meets these needs with a user-friendly interface that allows teams to manage their regulatory responsibilities with confidence and accuracy, enabling faster regulatory processes. Key features of Rimsys include automated tracking of product registrations and submissions, real-time updates on regulatory changes, and comprehensive reporting capabilities that can be utilized through existing business intelligence tools. These functionalities ensure regulatory teams can accelerate their time-to-market for new products, minimize the risks associated with non-compliance, such as recalls and expiration issues, and enhance drive growth. Rimsys transforms regulatory affairs from a traditionally reactive function into a strategic, revenue-driving component of the business, allowing companies to leverage compliance as a competitive advantage. By empowering MedTech companies to stay compliant and operate with greater efficiency, Rimsys helps to eliminate regulatory bottlenecks that can hinder innovation. The platform’s white-glove implementation approach ensures a smooth transition for organizations switching from other RIM providers, facilitating a better, faster, and more integrated experience. As a result, Rimsys stands out in the regulatory software landscape, providing tailored solutions that support the specific needs of medical device manufacturers and contribute to their overall success in a highly regulated environment.

Product Website

Seller

RIMSYS

Discussions

Rimsys Community

Languages Supported

English

Product Description

Rimsys is the only Regulatory Information Management (RIM) software built specifically for MedTech manufacturers. Our platform helps medical device and diagnostic companies streamline global regulatory processes by centralizing product registrations, submissions, standards, essential principles, and UDI data for EUDAMED compliance. Trusted by 6 of the top 12 MedTech companies, Rimsys replaces outdated systems with a modern, integrated solution that reduces risk, speeds time-to-market, and transforms regulatory affairs into a strategic revenue driver.

Overview by

James Gianoutsos (Founder and CEO)

Pricing

Pricing provided by Rimsys.

Medical Device Product Registrations

0 SKUs Per Year

View More Pricing Information

Rimsys Integrations

(3)

Verified by Rimsys

Rimsys Media

Rimsys is the only unified RIM platform, purpose-built for MedTech teams

Rimsys is the Trusted Regulatory Partner for 6 of the Top 12 Global MedTech Manufacturers

Rimsys AI: AI agents for your regulatory workflows

Official Downloads

(4)

edit

Executive Guide: RIM & AI Maturity in MedTech

Case Study: Global MedTech Registration Digitization

G2 reviews are authentic and verified.

Here's how.

Tara B.

Sr. Regulatory Affairs Specialist

Mid-Market (51-1000 emp.)

7/31/2025

"Rimsys is straightforward, logical, and an effective solution to managing market authorizations"

4.5/5

What do you like best about Rimsys?

Rimsys is intuitive and well-structured, making it easy to manage global market authorizations without getting lost in administrative complexity. I especially appreciate how logically the platform organizes regulatory documentation, submission timelines, and country-specific requirements. It reduces manual tracking and gives me confidence that nothing is slipping through the cracks. Review collected by and hosted on G2.com.

What do you dislike about Rimsys?

While Rimsys is highly effective, I’d like to see more flexibility in customizing workflows to match our internal processes around UDI structure. Some fields and templates feel rigid, and adapting them to niche regulatory needs—especially for legacy products with the current UDI structure—can be time-consuming. Review collected by and hosted on G2.com.

What problems is Rimsys solving and how is that benefiting you?

Before Rimsys, our team relied on a cumbersome SaaS solution to manage market authorizations—often requiring many clicks to perform a simple update, poor adoption by the external teams, and poor options surrounding reports and queries. It was difficult to maintain visibility across global registration, and adoption across the team was inconsistent due to the complexity of the workflow.

Rimsys simplifies and centralizes our regulatory processes. The platform’s logical structure and intuitive interface make it easier for team members to engage with and maintain regulatory data. By streamlining workflows and reducing administrative burden, Rimsys has significantly improved team adoption and collaboration. It’s helping us move toward a more scalable and compliant regulatory strategy. Review collected by and hosted on G2.com.

Response from Kelly Hoell of Rimsys

edit

We’re so glad Rimsys gives you confidence and clarity in managing global regulatory processes! Your feedback encourages us to continue simplifying complex workflows for all our users.

Graham M.

Regulatory Director

Mid-Market (51-1000 emp.)

8/14/2025

"RIM by Regs people for Regs people"

4.5/5

What do you like best about Rimsys?

We were an early adopter and found the system and team significantly better than the alternatives on the market at the time. I don't believe this position has changed, the others are trying to catch up!

System - A user-friendly UI makes navigation pretty straightforward, as an occasional user (though sponsor) I don't need help finding what I need. RIMSYS are continually improving the system, both in terms of usability and functionality with two big additions already this year.

Working with the team through implementation and upgrades, we've always been able to talk to an enthusiastic and and an engaged support team. Even the inevitable minor glitch is always dealt with quickly and efficiently. Review collected by and hosted on G2.com.

What do you dislike about Rimsys?

We've not experienced any major issues with Rimsys. As an earlier adopter, we did have an issue with having multiple manufacturing sites for one product (same reference and GTIN). This resulted in the way that our initial products were loaded causing a few issues after an upgrade and attempt to transition to the new method of uploading. Rimsys were able to resolve that with good and frequent communication with our team. Review collected by and hosted on G2.com.

What problems is Rimsys solving and how is that benefiting you?

Initially, it was about centralising our registrations and some of the supporting information. More recently, we have been using more of its' capabilities for building the registrations. Next to come is linking the product/country information to SalesForce so that our sales and marketing colleagues have instant access to the availability of a product in the market they are looking at (planning or selling). All of these save time for the Regs team which, in turn, gives them more time to undertake fulfilling work rather than wasting significant effort on administrative tasks. Review collected by and hosted on G2.com.

Response from Kelly Hoell of Rimsys

edit

Thank you for the kind words! We’re thrilled our system’s usability and our team’s support have made a difference. Hearing that we’re keeping ahead of the competition is especially motivating. We’re excited to keep improving and serving you!

Verified User in Medical Devices

Enterprise (> 1000 emp.)

10/17/2025

"One stop shop RIM System"

4/5

What do you like best about Rimsys?

This platform brings together all of our regulatory information in one place, including license approvals, registration lifecycles, product releases, and change management assessments.

My RA colleagues and I use the system every day and have engrained in our transformed culture and SOPs. The system is even more powerful when everyone is using it consistently. If use is not consistent through the regulatory organization, the benefit will be difficult to achieve.

Rimsys customer support is also very open to hearing our ideas, challenges, suggestions, and always offer up possible solutions along with implementation support. Review collected by and hosted on G2.com.

What do you dislike about Rimsys?

I sometimes encounter browsing errors, like the 'oops, you're lost' messages. These are particularly frustrating when I'm sharing my screen during a meeting and logged into the system. Review collected by and hosted on G2.com.

Response from Kelly Hoell of Rimsys

edit

Thank you so much for taking the time to share your detailed feedback! We’re thrilled to hear that Rimsys has become an integral part of your regulatory processes and daily workflows, helping to centralize documentation and drive efficiency across your team. It’s great to know that our platform and support team have contributed positively to your organization’s transformation and collaboration.

We appreciate your note about the occasional browsing errors — our product and engineering teams are actively working to improve system stability and reduce these interruptions. Your feedback is invaluable in helping us continue to enhance the platform experience.

Thank you again for your partnership and for being a part of the Rimsys community!

Verified User in Medical Devices

Enterprise (> 1000 emp.)

7/30/2025

"So Many Possibilities!"

5/5

What do you like best about Rimsys?

I like best how all the data links together so easily. There are so many opportunities for data tracking and analytics and at multiple levels, like customer code down to individual finished good numbers, or european union registrations down to individual member states. As we continue to expand our use of the system, we really see the opportunities to apply the system to multiple stages of our product lifecycle. We have also taken advantage of integration of rimsys with other company platforms. Lastly, we really appreciate the engagement with the Rimsys team. We have been running process improvement sprints this year and have provided feedback on opportunities which the Rimsys team is seriously evaluating to incorporate into their roadmap. Rimsys is now a daily tool for our department and I can't remember how we did things without it. Review collected by and hosted on G2.com.

What do you dislike about Rimsys?

There aren't necessarily aspects that I dislike, just opportunities for improvement for process efficiencies and reducing the burden on users. And with all development opportunities, they take time, which means we use procedural workarounds to manage around limitations. However, the Rimsys team continuously meets with our for feedback, so we are confident that improvements are on the way. Review collected by and hosted on G2.com.

Response from Kelly Hoell of Rimsys

edit

We’re thrilled Rimsys has become a daily tool for your team! It’s great to hear the system’s linked data, analytics, and integrations are helping across your product lifecycle. We also appreciate your feedback during process improvement sprints—it’s invaluable in shaping our roadmap.

Lucas N.

Global Regulatory Affairs

Enterprise (> 1000 emp.)

7/30/2025

"Strategic, user-friendly Regulatory Info mgmt system"

5/5

What do you like best about Rimsys?

In most use cases, the platform is very user friendly, panels/screens are intuitive to navigate and the system overall is not buggy for an online database mgmt software/platform. Review collected by and hosted on G2.com.

What do you dislike about Rimsys?

The one part that is not very user friendly is now to attach certificates/evidences of product approvals that are first, uploaded to the system, then linked to a registration entry item. The process is quite intricate and could be more straightforward. Review collected by and hosted on G2.com.

Response from Kelly Hoell of Rimsys

edit

We’re glad to hear Rimsys is intuitive, user-friendly, and running smoothly for your needs! Feedback like yours inspires us to keep building a reliable platform that makes managing regulatory data simple and seamless.

Verified User in Medical Devices

Enterprise (> 1000 emp.)

7/29/2025

"A RIMS platform designed by Regulatory professionals for regulatory professionals"

5/5

What do you like best about Rimsys?

I think what I find most useful about Rimsys is the fact that the system is designed intentionally. It has a friendly and aesthetically pleasing user interface, which I think is very important when you’re trying to incorporate a RIMS platform in your company. It’s logically built, with records in different modules being linkable to each other, which can make this a powerful platform. I also find that in general, it’s easy to use and easy to understand. Review collected by and hosted on G2.com.

What do you dislike about Rimsys?

Some of the functionality is not consistently featured across the platform. Review collected by and hosted on G2.com.

What problems is Rimsys solving and how is that benefiting you?

UDI data management and submissions, registration and submission document management, and regulatory assessments with accompanying tasks. Having all of these records in a single platform enables us to to understand our regulatory workload and c free are consistent processes across the organization. Review collected by and hosted on G2.com.

Response from Amy Baker of Rimsys

edit

Thank you so much for your review! We are so happy you are getting great value from the product and also appreciate your feedback on consistency of functionality.

Verified User in Medical Devices

Enterprise (> 1000 emp.)

8/7/2025

"Very happy with Rimsys and support team"

5/5

What do you like best about Rimsys?

The software is very user friendly, intuitive, and configurable to our needs. The module offering fits the needs of Regulatory Affairs very well. Review collected by and hosted on G2.com.

What do you dislike about Rimsys?

It is currently lacking the ability to search records based on one or more data fields (ex. all MDR Basic UDI records with a Risk Classification of Class IIa). There are some filters available but they are limited. Review collected by and hosted on G2.com.

What problems is Rimsys solving and how is that benefiting you?

Rimsys allows us to manage UDI submissions along with registrations and regulatory submissions in one system which decreases the learning curve for regulatory staff and minimizes the need to access/maintain other systems. It was important for us to manage data directly within the software as opposed to integrating into an external downstream database for UDI submissions. Review collected by and hosted on G2.com.

Response from Kelly Hoell of Rimsys

edit

We’re thrilled Rimsys helps your team manage UDI submissions, registrations, and regulatory workflows in one system! Reducing the learning curve and minimizing reliance on other tools is exactly what we aim for, and it’s great to hear it’s making a real difference.

Verified User in Medical Devices

Small-Business (50 or fewer emp.)

8/15/2025

"Great demo experience with RIMSYS"

5/5

What do you like best about Rimsys?

My experience with the Rimsys demo was more than I expected. It will certainly help to enable the registration and requirements process and take away the manual labor required to research requirements and ensure that you’re implementing them correctly. I look forward to implementation of the system for a more efficient registration process. Review collected by and hosted on G2.com.

What do you dislike about Rimsys?

I don’t think this is really a dislike, because I have not used the software yet beyond the demo, but I would like to see a future version of Rimsys become available that would help with the manual work of comparing versions of standards and create a gap analysis that can be cited on the technical files in the interim until the gap assessment is completed, And, that any new testing that required is determined in order to ensure compliance to the current applicable version of the standard. Review collected by and hosted on G2.com.

Response from Kelly Hoell of Rimsys

edit

Thank you for taking the time to share your experience! We’re thrilled to hear that the Rimsys demo exceeded your expectations and that you see the potential for our platform to streamline the registration and requirements process. Our team is committed to reducing manual effort and helping our customers implement regulatory requirements accurately and efficiently.

We also appreciate your thoughtful suggestions regarding gap analysis and version comparison—these insights help guide future improvements to make Rimsys even more powerful for our users. We’re excited to support you through implementation and look forward to helping your team achieve a more efficient registration process.

Verified User in Medical Devices

Mid-Market (51-1000 emp.)

8/1/2025

"Exceeded expectations"

4.5/5

What do you like best about Rimsys?

Seamless implementation, effective self-paced learning, intuitive workflow and support. Review collected by and hosted on G2.com.

What do you dislike about Rimsys?

The process to determine HOW to set up our products was lengthy, sometimes confusing and required a lot of discussion. With that said, the implementation team was patient and always willing to jump on a call to help guide us to the right decision. Review collected by and hosted on G2.com.

Response from Kelly Hoell of Rimsys

edit

It’s great to hear Rimsys’ dashboards and intuitive workflows are reducing manual effort and helping your team stay on top of regulatory submissions. We appreciate your collaboration during setup—it helps us continue delivering a seamless experience.

Janice K.

Regulatory Affairs Specialist I

Mid-Market (51-1000 emp.)

8/11/2025

"Rimsys has helped streamline various regulatory processes."

5/5

What do you like best about Rimsys?

Using Rimsys has eliminated several spreadsheets Review collected by and hosted on G2.com.

What do you dislike about Rimsys?

Some features cause extra steps that seem unnecessary Review collected by and hosted on G2.com.

Response from Kelly Hoell of Rimsys

edit

Thank you for sharing your feedback! We’re glad to hear Rimsys is helping streamline your workflows, eliminating spreadsheets, and making it easier to track international registrations, expirations, and submissions. We also appreciate your input on areas where extra steps exist—your insights help us improve the platform for all users.