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Why we developed Rimsys from the ground up

Wendy Levine

May 26, 2022

4 min read

Rimsys has had quite a year already! In early December, we closed on $16 million in Series A financing and since then we have been carefully growing the company to better serve our customers and the regulatory affairs community. We have almost doubled our employee count and redesigned the Rimsys system to deliver deeper functionality that is even easier to use. We had our first in-person employee meeting here in Pittsburgh at the end of April where we introduced our new mission statement, and we are all excited to be doing our part to improve global health!

All of these changes made us think back to the founding of Rimsys and how far we have come. So - I sat down with Rimsys Founder and CEO, James Gianoutsos, to talk about the genesis of the company and how he knew that a new type of system designed for medtech regulatory affairs professionals was needed, and needed to be built from the ground up.

Q: What was the biggest challenge you faced as a regulatory professional that led you to form Rimsys?

James: The biggest challenge I saw while working at Philips for many years was completely understanding the complexity and the nuances around everything regulatory from a product standpoint. This really came to light whenever we acquired products. Just seeing firsthand how inefficient and out of compliance these manufacturers really were, and how hard it was from an administrative standpoint just to get into compliance and then to stay compliant, was striking.

I was working with a smaller medical device company which had acquired products from Philips. Philips provided the company with a list (a color-coded Excel spreadsheet) of all of their products that the company had acquired along with the registration status of those products globally. After digging into the spreadsheet for several months, we found that about 50% of it was wrong, incomplete, or just completely missing. The company was trying to keep track of registration information, but the available tools were making it nearly impossible. I realized that this was the challenge, and that there really wasn’t a solution on the market that could solve that problem in an easy manner and in a medtech regulatory-focused way.

‍Q: There were solutions on the market that were geared more towards the pharmaceutical industry, correct?

‍James: Yes. So I did what every other regulatory professional did, which was to Google “regulatory software,” and I saw that there just really wasn’t anything on the market that fit our needs. The solutions on the market really were pharma-specific, even those that said they worked with medical devices. The workflows and regulatory requirements for medtech are very specific for each market, depending on the product type and risk class and so many other factors. To use a pharma system that was already on the market just wasn’t even an option because it was like comparing apples to oranges. It is completely different from the regulatory and workflow side of things.

‍Q: There are existing tools used by the regulatory community, such as quality management and document management systems. Did you envision the new RIM system integrating with existing tools, replacing them, or a little of both?

‍James: I never set out to replace those types of systems, no. In fact, I knew that existing system architecture and infrastructure couldn’t handle the specific medtech regulatory workflows but needed to connect to those systems. There have always been PLM (Product Lifecycle Management) systems that contain a company’s product master data, but those systems were never meant to be workflow-driven based on regulatory requirements. At the same time, they are critical for organizing and maintaining product-specific metadata. Then there are ERP systems, which are really about making sure companies have sales flags (i.e. regulatory blocks) in place, appropriate shipping codes, or selling status linked to product registration status. Regulatory professionals are concerned about answering two questions for ERP users; one, “does the product have a valid and current registration within the country or market,” and two, “if it is registered, are we selling and shipping into that market.” Lastly, quality/document management systems house critical documentation and records needed for registrations. The problem with these systems is that there are no regulatory workflows and no way to compile technical documentation, leaving the documents and records siloed from the regulatory filings.

To do the things that a regulatory affairs professional, in a critical regulatory department, does for their company, the system really had to be built from the ground up with all of these systems in mind. It had to be product-centric. It had to integrate with all these other sources of information, because there really wasn’t a common connection point between your products, your documentation, and the records that you needed to compile and how that relates to getting products on the market. We had no way to communicate to our other systems that a product is actually available for sale in that market or that it confidently can, or more importantly cannot, ship to that market.

‍Q: What was the most difficult piece of functionality to implement in Rimsys?

James: Well, at the time it kind of all seemed difficult! No, really the most difficult part was thinking thoughtfully and strategically about how data was going to be mapped and used in conjunction with other data elements, in order to make the system most helpful from a user perspective. We wanted to single-source information to enhance and streamline regulatory workflows, but then also make sure that it was as user friendly as possible. There are a lot of stakeholders that need information or have input into regulatory workflows. Quality assurance, marketing operations, R&D, engineering, sales - all of those specific stakeholders need to view information in a way that is understandable to them.

We worked hard to bring all that information, streamline complex regulatory workflows, and all of those internal and external data sources together in an understandable and user-friendly way.

Q: How important has the technology itself been in the creation of Rimsys?

James: Technology has been a huge advantage for us from day one. Our team had quality and regulatory backgrounds, so we knew what companies would expect from us. We knew we had to be 21 CFR Part 11 compliant. We knew we had to be ISO 27001 certified. We knew we had to have SOC2 Type 2 reports. We knew we had to integrate with a company’s existing IT infrastructure. We really had to build this thing from the ground up on a GxP compliant platform that we could build upon and expand, without having to go back and reinvent the wheel every time we added new functionality.

It’s continued to pay dividends for us because it was something that we thought about from the beginning and that gave us a lot of flexibility. We already had the system and infrastructure in place that we could then expand upon a lot more quickly than we would have been able to otherwise. It’s like the difference between building a house today and trying to remodel a house that was built in the year 1900. If you break down a wall in the older house, there might be so many hidden issues behind that wall - load bearing issues, knob and tube wiring, asbestos, etc. With new modern infrastructure, it is just night and day in terms of adapting quickly with changing regulations and a fast-paced market.

Q: Was there any specific technology you can talk about that became important to the development of Rimsys?

James: Our choice of technology was driven by our desire to build a system that was user friendly and built on a modern infrastructure that felt familiar to our users. So, we took a lot of the Google framework to build an application that didn’t look like enterprise software, but looked and felt more like a consumer product that is inviting, not overwhelming.

The other thing is that we built the system from day one to integrate because we knew we had to connect with a lot of different sources of information. We strategically built the system with API’s in mind.

Q: What is Rimsys doing differently than other software companies in the regulatory space?

James: We are creating a holistic solution, which is different from what is out there now. We know that registration management is just one key aspect of what regulatory affairs teams need. In order to create a proper regulatory system, we had to take into account all of the data and dependencies and build a system specifically for medtech regulatory teams and other key consumers of regulatory data. There has to be a single source of truth for this data, because otherwise it becomes a nightmare at the end of the day. Existing software solutions were siloed and purpose-built for other industry needs, such as eQMS, PLM and ERP. None of those systems can do what a holistic RIM platform can do. Because of the complex workflows, the regulatory needs are far too broad and interdependent, that data infrastructure is completely different, data sources are too numerous, and the systems offer limited support to bring everyone and everything together into a cohesive, streamlined, compliant and medtech-specific solution.

Another key component of what we are doing is to institutionalize regulatory knowledge and resources into Rimsys—this is at the heart of who we are and what we do. Having the only purpose-built, holistic RIM platform built by and for regulatory professionals specific for the medtech industry really couldn’t be done without internalizing that experience within our own team.

Q: What are you most proud of when it comes to Rimsys?

James: I think there are two things that immediately come to mind. Having our Rimsys 5 platform launch is really exciting. This is the fifth iteration of our platform, and we did it by listening to our customers and iterating over and over again to get it right. We had to go back to the drawing board a couple of times, not because what we had written wasn’t working, but because our customers that were using the system every day gave us better ways to do things. Rimsys 5 is a really proud moment because this is the platform that we are taking into the future, that will let us get to the next level where we are truly empowering regulatory professionals to make critical decisions and do the job that they are meant to do.

The ability for us to listen to our customers, take that feedback and move fast is the second thing I’d mention here. We know that this has to be a validated system, but we are able to make changes and add features in a way that is thoughtful and gets our customers what they need right away. Regulatory professionals are very particular. I know since I am one, and making sure they are comfortable using Rimsys from day 1 is critically important. Being a customer-centric company really makes our experience as a team extremely rewarding.

Q: Where is Rimsys going next? What are you most excited about?

I think I am most excited about Rimsys being an advocate for the medtech regulatory community and helping them wherever we can. Regulatory has a seat at the table now and it is a great feeling to see that we’re able to help these companies to streamline their workflows, accelerate time to delivery for life-saving products and maintain that compliance to keep those products on the market. Regulatory affairs is a mission critical department that the medtech industry cannot underestimate. It’s empowering because while we are helping our customers, they are helping us and every single one of our other customers through the journey of regulatory uncertainty that everyone is going through right now. It feels like a real partnership between us, our customers, and the industry as a whole and I am excited to see where that will take us.

I am also really excited about where we are going with regulatory intelligence. We are just scratching the surface of this now, but you will see regulatory intelligence data built into Rimsys and providing RA professionals with tools that can really provide a competitive advantage for their company. The release of Rimsys 5 platform (“Phase 1”) provides us that platform that will take us into “Phase 2” of Rimsys, with embedded intelligence that will further empower regulatory professionals to make decisive, correct and confident decisions for their products and their company.

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Registration deadlines don't have to be a risk. See how centralized data, automated alerts, and standardized workflows keep global registrations on track

How to Prevent Registration Deadline Misses in 2026

Bethaney Lentz

August 4, 2026

4 min read

A missed registration deadline can halt sales, trigger regulatory penalties, and damage your organization's credibility with health authorities. For MedTech regulatory affairs teams managing hundreds or thousands of product registrations across dozens of markets, preventing deadline misses requires more than calendar reminders. It demands structured data, clear workflows, and real-time visibility into expiration timelines.

This guide explains why registration compliance deadlines are missed and how your team can prevent delays through stronger data control, workflow visibility, and process standardization.

Key Takeaways: How to Prevent Registration Deadline Misses in 2026

Registration deadline misses typically stem from fragmented data, unclear ownership, and siloed communication between teams.

Proactive renewal management requires real-time visibility into expiration dates across your entire global product portfolio.

Standardized workflows with assigned accountability eliminate the confusion that leads to overlooked deadlines.

Rimsys centralizes registration data and automates renewal alerts, reducing the risk of missed deadlines by up to 90%.

Investing in a purpose-built RIM platform protects revenue continuity and maintains uninterrupted market access.

Why Do MedTech Teams Miss Registration Compliance Deadlines?

Registration deadline misses occur because the operating model cannot scale with growing portfolio complexity. Understanding root causes is the first step toward prevention.

Fragmented Data Across Systems and Regions

Many organizations track registrations using disconnected regional trackers, shared drives, and individual team member records. When product data lives in multiple locations, no single source of truth exists. This fragmentation makes it difficult to identify upcoming expirations before they become urgent.

A registration that expires in Brazil may be tracked in one system while the same product's EU approval is monitored elsewhere. Without connection between these records, teams lack portfolio-wide visibility into renewal timelines.

Unclear Ownership and Accountability

When responsibilities are distributed across regional leads, in-country partners, and distributors without clear accountability structures, deadlines fall through the cracks. Team members may assume someone else is handling a renewal, leading to inaction until the deadline passes.

Organizations with high turnover face additional risk. When key personnel leave, institutional knowledge about pending renewals often leaves with them.

Reactive Tracking Instead of Proactive Management

Calendar-based reminders and email notifications are inherently reactive. By the time a reminder appears, teams may not have enough runway to gather required documentation, coordinate with authorities, or address unexpected complications.

Effective deadline management requires proactive monitoring that surfaces upcoming expirations months in advance, not days before they occur.

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What Happens When Registration Deadlines Are Missed?

The consequences of missed registration deadlines extend beyond administrative inconvenience. They create tangible business disruptions that affect revenue, reputation, and regulatory standing.

Loss of Market Access and Revenue Disruption

An expired registration means your product cannot legally be sold in that market. Regulatory teams must halt shipments, distribution partners cannot fulfill orders, and revenue stops flowing. For high-volume products or critical markets, even brief interruptions to the supply chain can translate to significant financial impact.

Re-registering a lapsed product often takes longer than a standard renewal. Your team may face additional scrutiny, updated documentation requirements, or queue delays that extend the time to market restoration.

Regulatory Penalties and Increased Scrutiny

Health authorities track compliance history. Missed deadlines signal operational weaknesses that can trigger increased inspection frequency, additional documentation requests, or enhanced scrutiny on future submissions. Building trust with regulators takes years; eroding it takes one avoidable miss.

Damage to Distributor and Partner Relationships

In-country partners and distributors depend on your organization to maintain valid registrations. When market access lapses, partners bear the burden of explaining delays to healthcare providers and end customers. Repeated misses can damage long-term business relationships and competitive positioning.

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How to Identify Products at Risk of Deadline Misses

Prevention starts with identifying which registrations are most vulnerable. A systematic risk assessment helps teams prioritize attention and allocate resources effectively.

Create a Consolidated Registration Inventory

Bring all registration data into a single view. Include product identifiers, registration numbers, approval dates, expiration dates, responsible parties, and market-specific requirements. This inventory becomes your foundation for risk assessment.

Rimsys Registration Software centralizes this data automatically, linking registrations to products, submissions, and regulatory intelligence in one structured system.

Segment by Expiration Timeline and Complexity

Not all renewals carry equal risk. Categorize registrations by time remaining until expiration and by the complexity of renewal requirements. Products expiring within the next 90 days with extensive documentation needs should receive immediate attention.

Consider country-specific factors. Some markets require local testing, updated clinical data, or notified body involvement. These requirements extend lead times and increase the risk of delays.

Assess Documentation Readiness

For each at-risk registration, evaluate whether required documentation is current and accessible. Outdated technical files, missing test reports, or incomplete labeling information create bottlenecks that delay renewal submissions.

Documentation gaps discovered weeks before a deadline often cannot be addressed in time. Early assessment ensures enough runway to resolve issues.

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Building a Proactive Renewal Management System

Moving from reactive tracking to proactive management requires intentional process design. The following components form the foundation of an effective renewal management system.

Establish Clear Ownership for Every Registration

Assign a single accountable owner for each registration. This person is responsible for monitoring expiration timelines, coordinating renewal activities, and escalating issues that require additional support.

Ownership should be documented within your registration management system, not stored in separate organizational charts or email threads. When someone leaves the organization, ownership transfer becomes straightforward.

Define Standard Lead Times by Market and Product Type

Different markets have different renewal timelines. EU MDR renewals involve notified body coordination. FDA establishment registrations follow annual cycles. ANVISA submissions may require specific local documentation.

Document the standard lead time needed for each market and product type. Use these lead times to trigger renewal workflows well before deadlines approach.

Implement Automated Expiration Monitoring

Replace manual calendar tracking with automated monitoring that surfaces upcoming expirations across your entire portfolio. Alerts should trigger at multiple intervals, such as 180 days, 90 days, 60 days, and 30 days before expiration.

Automated monitoring ensures that no registration is overlooked, regardless of portfolio size or team bandwidth. Rimsys Global Regulatory Compliance capabilities include lifecycle tracking and automated alerts that reduce missed renewal risk.

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Standardizing Workflows to Prevent Oversight

Consistent workflows eliminate the variability that leads to deadlines. When every renewal follows the same structured process, teams can identify and address deviations before they cause problems.

Create Renewal Workflow Templates

Define the steps required for each type of renewal. Include documentation gathering, internal review, submission preparation, authority submission, and post-submission tracking. Assign responsible parties and expected durations for each step.

Templates ensure that new team members can execute renewals correctly without relying on undocumented institutional knowledge.

Build Escalation Paths for Delayed Activities

Not every renewal proceeds according to plan. Documentation may be delayed. Authority responses may take longer than expected. Partners may fail to submit required local information.

Define clear escalation paths that activate when activities fall behind schedule. Escalation should be automatic and visible, not dependent on individual team members raising concerns manually.

Conduct Regular Pipeline Reviews

Schedule recurring reviews of your renewal pipeline. During these reviews, examine registrations approaching expiration, identify any blocked activities, and confirm that responsible parties are on track.

Pipeline reviews surface potential issues early, when corrective action is still possible. They also reinforce accountability by making renewal status visible to leadership.

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How Data Control Reduces Deadline Risk

Strong data control is the foundation of reliable deadline management. When registration data is accurate, current, and accessible, teams make better decisions and avoid preventable misses.

Maintain a Single Source of Truth

Eliminate competing data sources by establishing one authoritative system for registration information. All team members, partners, and stakeholders should access the same data, ensuring consistency and reducing confusion.

A single source of truth means that when someone asks about a product's registration status in a specific market, the answer is immediate and reliable. No cross-referencing multiple trackers. No waiting for colleagues to respond to email inquiries.

Connect Registration Data to Product and Submission Records

Registrations do not exist in isolation. They connect to specific products, rely on previous submissions, and may be affected by regulatory changes or product modifications. Systems that link these data types enable more accurate impact analysis.

When a product design change occurs, connected data helps teams identify which registrations may need updated. When regulations evolve, linked intelligence shows which markets and products are affected.

Ensure Version Control and Audit Readiness

Regulatory authorities expect organizations to demonstrate controlled processes. Maintain version history for all registration-related documentation. Track who made changes, when changes occurred, and what was modified.

Audit readiness built into daily operations means less scrambling when inspections occur. It also shows the historical context needed to understand how registration status evolved over time.

Leveraging Technology for Visibility and Automation ‍

Technology plays a critical role in scaling deadline management across large portfolios. Purpose-built regulatory information management platforms offer capabilities that generic tools cannot match.

Dashboard Visibility Across Global Markets

Executive and operational dashboards display at-a-glance visibility into registration status across your entire portfolio. Filter by market, product line, expiration timeline, or responsible party, to focus on relevant subsets.

Dashboard visibility enables leadership to ask and answer questions quickly:

How many registrations will expire in the next quarter?

Which markets have the highest concentration of upcoming renewals?

Are any renewals currently blocked?

Automated Alerts and Notifications

Configure alerts that notify responsible parties when action is required. Notifications should be specific, actionable, and timely. Rather than generic reminders, alerts should identify the specific registration, required action, and deadline.

Effective notification systems reduce the cognitive burden on team members. Instead of tracking deadlines mentally, they receive prompts when attention is needed.

Reporting for Continuous Improvement

Track metrics that indicate process health. Monitor the number of registrations renewed on time, average lead time utilization, and frequency of expedited renewals. Use these metrics to identify process weaknesses and drive improvement.

Organizations that measure renewal performance can demonstrate compliance maturity to regulators, partners, and investors. Metrics also help justify investments in process improvement.

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How Rimsys Helps Prevent Registration Deadline Misses

Rimsys is the first and only holistic Regulatory Information Management software purpose-built for MedTech. It centralizes registrations, submissions, regulatory intelligence, and UDI data in one connected platform, giving teams the visibility and automation needed to prevent deadline misses.

Centralized Global Registration Tracking

Rimsys maintains a structured, product-centric data model that connects registrations to products, markets, and submissions. Teams gain real-time visibility into where every product can be sold, which registrations are pending, and which are approaching expiration.

Six of the world's top 12 MedTech manufacturers trust Rimsys to manage global regulatory operations, achieving up to 90% reduction in reporting effort and elimination of manual tracking risk.

Automated Lifecycle Alerts

Rimsys monitors registration lifecycles and automatically alerts teams to upcoming expirations, renewals, and information requests. Automated alerts ensure that no registration is overlooked, regardless of the portfolio size.

With Rimsys AI, teams can accelerate regulatory work through AI-assisted workflows that reduce repetitive tasks while keeping human judgment in control.

Connected Regulatory Intelligence

Registration deadlines do not exist in isolation from regulatory change. New requirements can affect renewal timelines, documentation needs, or market access conditions.

Rimsys connects registration data to regulatory intelligence and impact assessment workflows, helping teams understand how changes affect their portfolio before deadlines become urgent.

Creating a Culture of Deadline Accountability

Technology and process alone do not prevent deadline misses. Organizations must also cultivate a culture where deadline accountability is valued and reinforced.

Make Renewal Performance Visible

Share renewal metrics with teams and leadership regularly. Celebrate on-time renewals and analyze near-misses to identify improvement opportunities. Visibility creates accountability without requiring punitive measures.

Invest in Team Training and Development

Ensure that team members understand the importance of deadline management and have the skills to execute renewal workflows effectively. Training should cover both procedural requirements and the business impact of missed deadlines.

Support Cross-Functional Collaboration

Registrations often require input from quality, engineering, labeling, and commercial teams. Foster collaboration across functions to ensure that dependencies are identified early and addressed proactively.

When regulatory affairs teams operate in silos, they lack the information needed to anticipate complications. Cross-functional visibility enables earlier intervention.

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In Conclusion: How to Prevent Registration Deadline Misses

Preventing registration deadline misses requires intentional effort across three dimensions: data control, workflow visibility, and process standardization. Organizations that invest in these areas protect revenue continuity, maintain regulatory standing, and preserve partner relationships.

The complexity of global regulatory operations is not slowing down. As portfolios expand and requirements evolve, teams need infrastructure that scales. Rimsys transforms regulatory operations from administrative tracking into strategic enablement, bringing speed, visibility, and confidence to global expansion.

Ready to eliminate deadline risk from your registration management? Speak with the Rimsys team to see how leading MedTech manufacturers manage global registrations with precision and control.

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References:

How to Register and List a Medical Device with the U.S. FDA

Medical Devices and EUDAMED in Europe

U.S. FDA, Code of Federal Regulations, Title 21, Subchapter H, Part 807

IMDRF (International Medical Device Regulators Forum)

ISO 13485, Medical Devices

How Smith & Nephew Repositioned Regulatory as a Strategic Commercial Partner

Caroline La

May 28, 2026

4 min read

Smith & Nephew is a global medical device manufacturerwith a broad portfolio spanning orthopedics, sports medicine, and woundmanagement, sold and registered across markets worldwide. Before Rimsys,regulatory data was scattered across spreadsheets, shared drives, anddisconnected systems.

When Smith & Nephew selected Rimsys, they deployed enterprise-wide from day one. Executive reporting moved from manual fire drills to real-time dashboards. Change impact assessments became faster and more consistent. The regulatory team made the shift from reactive compliance function to strategic partner to the business.

The Challenge

Regulatory data at Smith & Nephew lived in multiplespreadsheets, shared drives, SharePoint sites, emails, and disconnectedsystems. Without a centralized record, the team could not reliably trackregistration timelines, measure on-time submissions, assess change impacts, orunderstand the downstream impact of product changes across markets. Preparingexecutive reporting meant manually assembling data from multiple sources, aprocess that consumed time and introduced risk each time.

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The Solution

Smith & Nephew selected Rimsys for its configurable, notcustomized, platform: an intuitive user interface, centralized submissionmanagement, robust metrics, change assessment capabilities, and UDI supportwith machine-to-machine transmission. Rimsys’ interconnected modulearchitecture linked products, registrations, projects, change assessments, andUDI in a centralized location.

Rather than piloting in one business unit, Smith &Nephew deployed Rimsys across the entire regulatory organization from day one.The decision was deliberate: a partial deployment would have preserved thefragmentation. Enterprise-wide adoption established consistent metrics,standardized processes, and a single source of truth from the start.

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The Results

Executive and board reporting, previously built from manualdata pulls, now flows directly from Rimsys in real time. What had been adisruptive, recurring effort is now a routine view. Leadership has thevisibility to make faster, more confident decisions, and the regulatory team isno longer pulled into reporting fire drills.

Change management has also been transformed. Direct linkagebetween products, registrations, and projects means impact assessments arefaster and less dependent on individual knowledge. UDI operations havesimilarly improved: machine-to-machine transmission has reduced manual uploadsand centralized DI record visibility supports global UDI requirements.

The most significant shift is strategic. With centralizedregulatory intelligence and real-time data, Smith & Nephew’s regulatoryteam now actively supports commercial planning: informing budget cycles,guiding renewal and launch sequencing, and advising on regulatory pathways toaccelerate market entry. Regulatory is no longer a downstream compliancefunction. It is a business partner.

Smith & Nephew now runs four modules across its RIM operation:

Registrations— Centralized license tracking across 250 countries and 30+ business units
Change Assessments— Direct product-registration linkage for faster, consistent impact assessments
Executive Reports— Real-time dashboards replacing manual data pulls and board reporting fire drills
UDI— Machine-to-machine transmission reducing manual uploads across global markets

Take this to your team

If you’re evaluating how to modernize RIM operations at scale, the Smith & Nephew case study is a practical reference to share internally. It covers the full implementation story, module breakdown, and results data in a format built for stakeholder conversations.

Download the Case Study

How Philips Scaled Active Product Registrations More Than 20x

Caroline La

May 21, 2026

4 min read

Philips Healthcare operates one of the largest regulatory portfolios in global MedTech: products registered across 250 countries, with a footprint that grows with every acquisition. Before Rimsys, that complexity was managed through email and spreadsheets. Submission packages moved through inboxes with no audit trail, no performance data, and no reliable view of where products were authorized to ship.

Philips selected Rimsys in 2022 as the enterprise RIM platform to bring regulatory order to that complexity. Since go-live, active product registrations have scaled more than 20x, user adoption has doubled in the last six months, and the regulatory affairs function now operates from a single source of truth spanning the entire enterprise.

The Challenge

Without structured data, Philips could not measure regulatory performance, track license expiration across the portfolio, or identify where submission work was stalling. Every acquisition made it worse: incoming business units arrived with their own workflows and systems, absorbing more fragmentation rather than resolving it.

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The Solution

Philips evaluated multiple platforms against requirements built with both market-facing and business regulatory affairs teams. Rimsys won on two dimensions: an interface that made complex product and registration data immediately visible, and more enterprise-ready features than competing platforms at the right price point.

Philips went live with Rimsys Registrations and Submissions modules in July 2022. The team deployed platform experts for train-the-trainer sessions and launched regular drop-in sessions where users could ask questions and surface issues. Standing up a dedicated Regulatory Operations team focused exclusively on rest-of-world registration accelerated adoption further.

When an early business unit pushed back on workflow efficiency, Philips and Rimsys worked through it together. A hands-on process walkthrough identified exactly what needed to change, a resolution plan was shared, and that transparency and collaboration became the foundation for sustained user buy-in across the enterprise.

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The Results

Since go-live, Philips has scaled active product registrations more than 20x, with further growth already underway. What started as a single deployment now spans 30+ business units across 250 countries, with Rimsys serving as the single source of truth for regulatory data across the enterprise, including businesses acquired since implementation.

For the first time, Philips can measure its own regulatory performance. KPIs flow directly from the platform, giving leadership real-time visibility into registration health. When anomalies surface, they drive data correction and user training, closing gaps that previously went undetected until they affected revenue.

Now with Rimsys AI-assisted Submissions and Regulatory Intelligence now in use, Philips expects to accelerate further: reducing administrative burden so skilled regulatory professionals can focus on strategy.

Philips now runs four modules across its RIM operation:

Registrations— Centralized license tracking across 250 countries and 30+ business units
Submissions— AI-assisted submission workflows replacing email-based package management
Intelligence— Real-time KPI dashboards giving leadership visibility into registration health
Standards— Essential Principles and standards tracking aligned to global market requirements

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Take this to your team

If you’re evaluating how to modernize RIM operations at scale, the Philips Healthcare case study is a practical reference to share internally. It covers the full implementation story, module breakdown, and results data in a format built for stakeholder conversations.

Download the Case Study