Creating regulatory order for the medical device industry.

Medical device companies want their products in the hands of the people who need them the most. However, the digital maze of global regulations is constantly shifting and is loaded with dead ends and delays that put businesses at risk. Companies are finding it increasingly difficult to ensure that their products adhere at all times to the constantly changing and evolving regulations and need a streamlined solution for ensuring compliance.

Welcome to RIMSYS.

Join the Digital Revolution of Regulatory Affairs

Testimonials

“If you’re a medical device regulatory professional…I promise you, [RIMSYS] will change your life in a good way.“

Jon SpeerFounder & VP of QA/RA at Greenlight Guru

“Simple…Powerful…the structure and convenience this can bring to my team and our international partners is a GAME CHANGER.“

Eric RockManager of QA/RA at LiteCure

“No alternative even comes close to RIMSYS.“

JoseRA Manager at a leading medical device monitoring company

Why Teams Demand RIMSYS.

Notoriously understaffed, regulatory teams and personnel can make or break a product’s entry. Give them the right tools so they can do their job.
An undersaturated talent pool creates a critical need for employees to manage their workloads more efficiently.
Free up time to focus on tasks that improve your bottom line, rather than time-consuming and burdensome administrative duties.
Collaboration is key. Disjointed processes, color-coded excel files, and emails lost in the shuffle inhibit progress. Keep everyone on the same page with a single platform solution.

Why Companies Depend on RIMSYS.

Companies demand up-to-date regulatory data to stay compliant and legal. RIMSYS delivers this intelligence to your fingertips with real-time alerts.
Entering into a new market is a strategic business decision. RIMSYS provides the clarity needed to ensure entrance isn’t delayed by letting you know what you’re up against.
Time-to-market is of the essence. Allowing your company to execute in harmony is crucial. RIMSYS ensures critical business revenue isn’t missed when opportunities arise.
Building an in-house archive of intelligence empowers your company. RIMSYS provides a seamless transfer of knowledge between internal teams and outside organizations which reduces the need for hiring outside help.

Why the Market Needs RIMSYS.

The medical device industry is highly regulated, complex, dynamic and differs between countries. RIMSYS provides decision makers a way to navigate the market for success.
Regulations are changing faster and becoming more complicated now than at any other time in history. RIMSYS tames this trend by adding order to chaos.
RIMSYS provides a means to stay proactive instead of reactive when companies can’t grasp the regulatory landscape and how it impacts their business.

Powerful Integrations

Integrate your existing Quality Management System (QMS) documentation and records directly into RIMSYS and easily sync into your existing ERP/PLM software.
No manual or time consuming administrative activities needed.

and more…

How We Help

Global Product Registrations

Medical device registrations are mandatory for most countries prior to selling and the registration process is long, complex, and involves many internal and external people

Tired of incorrect color-coded excel files managing your product registrations?
Tired of performing the administrative duties of organizing critical documents?
Can’t keep your regulatory, sales, and customer service teams on the same page?

Learn How We Help

with Medical Device Global Product Registrations

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Standards Management

Medical device manufacturers must stay current to “state of the art” requirements. This means that companies must actively monitor for changing regulations and standards

Can’t keep track of all your standards and which products they are linked to?
Tired of being surprised at audits about changed standards?
Can’t afford to redo product testing?

Learn How We Help

with Standards Management

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Essential Principles

Essential Principles are fundamental design and manufacturing requirements that, when met, indicate a medical device is safe, performs as intended, and conforms to the regulations that apply in each jurisdiction

Can’t keep track of all your standards within each essential principles table?
Can’t actively manage the 50-page document for each of your product lines?
Tired of reinventing the wheel each time an essential principles document is created?

Learn How We Help

with Essential Principles Management

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Our Solutions

Product Registrations

Track registrations, renewals, expirations, notes, tasks, important dates, regulatory documents, and collaborate with in-country sponsors and distributors.

Receive Renewals & Expiration Reminders
Manage Regulatory Documents
Grant Access to Anyone

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Standards Management

We have every standard you need. Track, link and get notified of changing standards.

Never Miss a Standards Update Again
Link Standards to Product Profiles
Determine Impact to your Products and Company

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Essential Principles

The FIRST and ONLY software created for a products’ essential principles! Collaborate, link standards, apply evidence, and get notified when standards change.

Actively Manage the Technical File
Comply to the New EU MDR
Maintain an Audit Log of all Activities

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Regulatory Insight

When regulations and laws change that may affect your products and where they are registered, receive timely notifications and insight into regulatory updates.*

*Coming Soon

Bringing it all together

A collaboration hub for all your regulatory needs

Products

Create, edit, and maintain product profiles in a fully integrated platform. Understand the relationships between your products, standards, accounts, contacts, and countries, ensuring that you know EXACTLY how a product is affected by changing requirements.

Regulatory Documents

Approve and retain documents, including your products’ essential requirements, in compliance with 21 CFR Part 11.

Countries

Manage the countries where your products are sold and/or registered. Keep track of regulations, tasks, and documentation.

Regulatory Intelligence

Make sure you are on the right regulatory path by keeping track of the regulations that affect your business and your products.

Accounts & Contacts

Keep detailed notes on communications, upload documents, and keep track of important audit and registration data for your notified body, service providers (e.g. electrical safety certificate), country sponsors, distributors, and more.

Certificates

Keep track of your expiring product and company certificates.

Reports

Generate reports for management review and cross-functional meetings.

Other Great Features

100% Cloud-Based
By offering one version of code and a simplified delivery approach, we can focus on execution and innovation.
Scalable
RIMSYS grows with your business. If you are a small business looking to become a global powerhouse, or a business already in every country in the world, we are ready.

Simplified Pricing
There are no hidden, overage, or maintenance costs. RIMSYS offers simple pricing so there are no surprises.
Transparency
We keep you informed of planned maintenance, system downtimes and any interruptions to service.

RIMSYS was developed by regulatory professionals for regulatory professionals

Compliant with EU laws, data security, and confidentiality. Your business should be global, and the software you use should be no exception.

RIMSYS was built from the ground up, completely customized utilizing GxP platforms and industry best practices. We are built for the regulated industry.

RIMSYS is always audit-ready. We know audits can be stressful and you have enough to worry about, so let us worry about the regulations.

Compliance with 21 CFR Part 11 is a must for the regulatory industry when dealing with signatures and record retention. We got you covered.

Security is our #1 priority when dealing with your data and information. Redundancy and up-to-date encryption methods are always in place. We’re on top of it, so you don’t have to be.

Want to Know More?

Contact Us Now!

RIMSYS Regulatory Management Software is a collaboration hub to help medical device companies actively navigate the changing regulatory landscape. RIMSYS offers a suite of cloud-based regulatory affairs software solutions for the medical device industry to manage global product registrations, standards, essential principles, regulatory documents, and more.

Creating regulatory order for the medical device industry.

Join the Digital Revolution of Regulatory Affairs

Testimonials

Why Teams Demand RIMSYS.

Why Companies Depend on RIMSYS.

Why the Market Needs RIMSYS.

Powerful Integrations

How We Help

Global Product Registrations

Learn How We Help

Standards Management

Learn How We Help

Essential Principles

Learn How We Help

Our Solutions

Product Registrations

Standards Management

Essential Principles

Regulatory Insight

Bringing it all together

Products

Regulatory Documents

Countries

Regulatory Intelligence

Accounts & Contacts

Certificates

Reports

Other Great Features

100% Cloud-Based

Scalable

Simplified Pricing

Transparency

RIMSYS was developed by regulatory professionals for regulatory professionals

Contact Us Now!

Solutions

Sales & General Inquiries

Software Support

Location

Legal