Rimsys Launches the Regulatory Execution Engine for MedTech. Spring 2026 embeds submission authoring, AI-powered regulatory monitoring, and configurable impact workflows inside a single RIM platform, the first step toward Rimsys' AI vision for global regulatory operations. PITTSBURGH-(BUSINESS WIRE)-Regulatory Information Management (RIM) software was built to store records. That foundation has served its purpose and reached its limit. Today, Rimsys announces the Spring 2026 release: a platform designed not to hold regulatory data, but to execute on it. "Our vision for Rimsys is a platform that makes regulatory expertise go further, companies move faster, and products reach more markets than any team could accomplish alone. Spring 2026 is another meaningful step toward that vision." Share Submission volumes are growing. Markets are multiplying. Regulatory change is accelerating. Spring 2026 gives regulatory teams the tools to keep pace: embedded authoring, reusable submission content, configurable impact workflows, and AI-powered intelligence, all inside a single platform. "Our vision for Rimsys is a platform that makes regulatory expertise go further, companies move faster, and products reach more markets than any team could accomplish alone. Spring 2026 is another meaningful step toward that vision. We are embedding the tools and intelligence that allow regulatory affairs professionals to operate at a different level, doing more strategic work, entering markets faster, and staying ahead of regulatory change rather than reacting to it. What we are building next makes this release the starting line." - James Gianoutsos, CEO What Spring 2026 Delivers A brand new website that provides in-depth information about the Rimsys offering and the benefits to MedTech manufacturers, including details on these new products: Intelligence: AI-Powered Regulatory Monitoring Rimsys Intelligence provides access to regulations, guidance documents, safety alerts, and legislation across more than 90 countries. AI triage and prioritization surface the updates most relevant to each customer's specific products and markets, eliminating hours of manual surveillance and putting the right information in front of the right people. When a change requires action, teams can move directly from regulatory signal to impact assessment without a manual handoff. Intelligence represents Rimsys' first production deployment of context-aware AI operating across a customer's live regulatory data, a foundation that will expand significantly in future releases. Advanced Submissions: A Unified Submission Execution Workflow Advanced Submissions consolidates everything required to create, manage, and publish a regulatory submission into a single workflow inside Rimsys, eliminating the disconnected tools, manual reformatting, and version fragmentation that have defined submission work for too long. Three capabilities anchor it: Rimsys Editor The Rimsys Editor is the cornerstone of Advanced Submissions and the most significant capability in this release. It brings word-compatible authoring and editing natively inside Rimsys, fully compatible with Microsoft Word(R), allowing regulatory teams to create, co-author, review, and publish submission content without leaving the platform for the first time. The Editor supports real-time co-authoring, tracked changes and redlining, rich content including tables and images, document comparison, and PDF publishing with standardized headers, footers, and company branding applied automatically. AI-assisted authoring is available as a configurable option, enabling teams to summarize, refine, expand, and translate content within their workflow. Rimsys AI is human-in-the-loop by design. Universal Submissions Universal Submissions enables teams to build from a single universal template (an IMDRF Technical Document) with content automatically mapped into market-specific templates. One master structure, many markets, without rebuilding from scratch. Reusable Submissions Reusable Submissions takes a completed submission from one market and uses it as the starting point for a new one. The system automatically maps content into the target market's template, carrying applicable sections forward reducing the content creation time up to 90% and compressing the time required to enter each additional market. Configurable Impact Surveys: Governed Change Assessment at Scale Impact Surveys are now fully configurable. Templates can be defined for specific change event types, tied to countries or registrations, and triggered automatically from Rimsys Intelligence findings replacing ad hoc assessments with repeatable, governed workflows. This integration creates a direct line from change event to regulatory scope, with results tracked in a single audit-ready trail. A Platform Built for What's Next Spring 2026 establishes more than a set of new capabilities. It establishes the execution infrastructure, structured data model, and embedded AI foundation on which Rimsys' longer-term vision is being built. That vision: a world where regulatory experts are amplified by intelligence, not constrained by information. Where the knowledge required to enter a new market, interpret a regulatory change, or scope a submission is instantly available to every member of the team. Where regulatory operations scale not by spreading experts thin, but by giving them tools that multiply their impact. Spring is the first production step in that direction. Every submission authored inside the platform, every intelligence signal triaged by AI, and every impact assessment connected to structured regulatory data deepens the foundation. Future releases will build on it directly, expanding AI capabilities, automating more of the regulatory workflow, and ultimately enabling teams to do work that today requires external expertise to be done inside Rimsys. Regulatory Execution as a Business Lever Spring 2026 is built to move metrics that matter: reduced submission cycle time variance, improved approval predictability, lower marginal effort per market, and increased team capacity without proportional headcount growth. For executive leadership, earlier approvals translate directly into faster market access and accelerated revenue recognition. Availability Spring 2026 is now Generally Available. Existing customers on the Organizer product will retain access to their current experience. To learn more about the Spring 2026 release and how Rimsys can accelerate your regulatory operations, visit rimsys.io or contact your Rimsys representative. About Rimsys Rimsys is the heart of regulatory operations for the medical device industry and the platform at the center of an AI-driven transformation in how regulated products reach global markets. A living, connected regulatory platform, Rimsys keeps regulatory intelligence, product data, approvals, and change management continuously connected, enabling organizations to expand into global markets with speed, precision, and confidence. Enterprise-ready yet intuitive to use, Rimsys is trusted by 6 of the top 12 global MedTech manufacturers to accelerate time to market and scale regulatory operations worldwide. To learn more, visit rimsys.io. More News From Rimsys PITTSBURGH-( BUSINESS WIRE )-Rimsys, the global leader in Regulatory Information Management (RIM) software for the MedTech industry, today announced two major enhancements to its platform: expanded Unique Device Identification (UDI) capabilities to support EUDAMED machine-to-machine (M2M) bulk transmission and Rimsys Connect(TM), a new enterprise Change Data Capture (CDC) solution that provides near real-time synchronization of Rimsys data with customers' Business Intelligence (BI) solutions. Toge... PITTSBURGH-( BUSINESS WIRE )-Rimsys, the global leader of MedTech Regulatory Information Management (RIM) software, today announced that it has entered into a strategic alliance relationship with KPMG to advance digital transformation in the MedTech industry. "KPMG's deep experience in advisory and business transformation services and exceptional reputation make them a valuable alliance relationship for us," said James Gianoutsos, Founder and CEO of Rimsys. "KPMG is on the cutting edge of indus... BERLIN-( BUSINESS WIRE )-Rimsys announced today the beta launch of its free, centralized global regulatory intelligence hub for the medtech community, Rimsys Intel... Rimsys. Headquarters: Pittsburgh, PA CEO: James Gianoutsos Employees: 50 Organization: PRI Release Summary Rimsys Launches the Regulatory Execution Engine for MedTech: Spring 2026 is the first step toward Rimsys' AI vision for global regulatory operations. Release Versions

Rimsys enters strategic alliance relationship with KPMG.

Rimsys, developer of a cloud-based regulatory software designed to help medical device companies actively track the regulatory landscape, raised $5.3 million through a combination of Series AA-1, and Series AA venture funding from Riverfront Ventures, Innovation Works and GO Philly Fund putting the company's pre-money valuation at $21 million.