Rimsys Reviews & Product Details

Rimsys is a comprehensive MedTech software platform designed to streamline regulatory operations for manufacturers in the medical technology sector. By integrating AI-native market planning with AI-embedded regulatory execution, Rimsys provides a unified system that guides users from the initial market-entry decision through to the execution of regulatory requirements. This innovative approach enables teams to navigate the complexities of regulatory landscapes efficiently and effectively. The platform consists of two primary components: Rimsys Market Access and Rimsys Regulatory Information Management (RIM). Rimsys Market Access serves as the planning layer, equipping teams with the necessary tools to evaluate potential market entry. It offers insights into classification, regulatory pathways, timelines, and associated costs, allowing teams to make informed decisions before allocating budget or resources. This proactive planning capability is crucial for organizations looking to optimize their market strategies and minimize risks associated with regulatory compliance. On the execution side, Rimsys RIM software manages essential tasks such as registrations, submissions, regulatory changes, Unique Device Identification (UDI), and ongoing compliance. By centralizing these functions, Rimsys enables teams to implement their market access plans with confidence. The seamless integration of planning and execution ensures that all regulatory intelligence, product data, approvals, and change management processes are continuously connected, facilitating a smoother transition into new markets. Rimsys is trusted by six of the top twelve global MedTech manufacturers, underscoring its reliability and effectiveness in the industry. The platform is certified to ISO 27001 and SOC 2 standards, ensuring robust security and data management practices. Additionally, Rimsys is in the process of obtaining ISO 42001 certification for its AI management systems, further demonstrating its commitment to maintaining high standards in regulatory operations. By leveraging Rimsys, organizations can enhance their regulatory intelligence and operational efficiency, ultimately leading to faster market entry and sustained compliance in a dynamic regulatory environment.

Seller

RIMSYS

Discussions

Rimsys Community

Languages Supported

English

Overview by

James Gianoutsos (Founder and CEO)

Pricing

Pricing provided by Rimsys.

Basic

$1.00

Usage Based Per Year

View More Pricing Information

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Verified User in Medical Devices

Enterprise (> 1000 emp.)

10/15/2026

"Intuitive Rimsys UI and Flexible Surveys Drove Smooth Adoption"

5/5

What do you like best about Rimsys?

The intuitive and user-friendly Rimsys interface significantly simplified training and supported the successful adoption of the new module by over 200 users. The enhanced survey customization enables the Impact Survey template to accommodate client-specific business and regulatory needs. Review collected by and hosted on G2.com.

What do you dislike about Rimsys?

There are no aspects that I dislike but opportunities for improvement and Rimsys Team has always been receptive or open to our suggestions. Review collected by and hosted on G2.com.

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

Collecting feedback from global regulatory teams to assess product changes can be a significant administrative burden. The enhanced survey customization allows the Impact Survey template to not only accommodate client-specific business and regulatory needs, but also support faster turnaround times. It also provides a dashboard to monitor response progress. Review collected by and hosted on G2.com.

Response from Kelly Hoell of Rimsys

Thank you for this! Getting more than 200 users onto a new module is no small thing, so we’re really happy to hear the interface made training easier.

It’s also great to hear the survey customization is paying off. We know collecting feedback from global regulatory teams can eat up a lot of time, so faster turnaround and a clear view of who has responded is exactly what we were going for.

We appreciate your suggestions, too. A lot of what we build comes straight from customers like you, so please keep sending them our way.

Verified User in Medical Devices

Mid-Market (51-1000 emp.)

Originally submitted 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

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.

Tara B.

Sr. Regulatory Affairs Specialist

Mid-Market (51-1000 emp.)

Originally submitted 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

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

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

Mid-Market (51-1000 emp.)

2/11/2026

"Centralized Regulatory Hub That Streamlines Audits and Market Authorizations"

4.5/5

What do you like best about Rimsys?

The Rimsys platform supported our notified body audit by centralizing product registration data, enabling same-day responses to auditor inquiries. Through centralized tracking of market authorizations in Rimsys, the audit concluded with no nonconformances related to device marketing authorization. The platform continues to serve as our global regulatory hub, helping teams efficiently access and document market release authorizations.” Review collected by and hosted on G2.com.

What do you dislike about Rimsys?

Some bulk actions are lacking. Some modules are less refined than others. Review collected by and hosted on G2.com.

Response from Kelly Hoell of Rimsys

Thank you so much for taking the time to share your experience with Rimsys on G2. We’re thrilled to hear that the platform helped support your notified body audit by centralizing product registration and market authorization data, enabling your team to respond quickly and confidently to auditor inquiries.

It’s especially rewarding to know that Rimsys contributed to an audit outcome with no nonconformances related to device marketing authorization — that’s a huge accomplishment for your team.

We also appreciate your honest feedback regarding bulk actions and module refinement. Enhancing usability and expanding bulk capabilities are active areas of focus for our product team, and input like yours helps guide those improvements.

Thank you again for trusting Rimsys as your global regulatory hub. We’re excited to continue supporting your regulatory and market access efforts worldwide.

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

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

Mid-Market (51-1000 emp.)

4/15/2026

"Intuitive Data Aggregation, But Needs More Flexible Basic Product Information Display"

5/5

What do you like best about Rimsys?

It is intuitive and easy to use. Will be a valuable tool. Review collected by and hosted on G2.com.

What do you dislike about Rimsys?

We are currently integrating and can add additional details at a later time. Review collected by and hosted on G2.com.

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 us 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

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

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.

Response from Amy Baker of Rimsys

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.