Rimsys Announces AI-Native Market Access for Regulated Products

New software gives regulatory and commercial leaders a source-linked, actionable view of market viability, requirements, timing, and risk before committing resources

PITTSBURGH--(BUSINESS WIRE)--Rimsys, the heart of medtech regulatory operations, today announced Market Access, a new AI-native product designed to help companies determine whether a market is worth entering and what it will take to get there. Market Access will be available in beta beginning September 1, 2026, with general availability to be announced separately.

Market Access replaces what can be a 6-to-9-month research and assessment process with a same-day, actionable read on market viability. It gives regulatory and commercial leaders the classification, pathway, timeline, cost considerations, and potential regulatory gaps they need to make a more defensible investment decision before committing budget and resources.

Predictability is at the core of Market Access. Rather than simply identifying a regulatory pathway, it helps teams understand what to expect, which requirements or gaps are most likely to slow down a submission, and where uncertainty remains. Every answer traces back to the specific regulation, guidance, or law behind it, allowing regulatory professionals to verify the underlying source rather than simply trust an AI-generated response.

Key features and benefits include:

• Same-day market assessment: Provides an actionable read on whether a market is worth entering, replacing research and assessment that can take 6 to 9 months.
• Cross-designation classification: Evaluates products across medical device, IVD, cosmetic, consumer, and OTC designations, so the same product receives the appropriate regulatory read regardless of how a given market classifies it.
• Clear market-entry requirements: Provides classification, regulatory pathway, timeline, cost considerations, and key requirements before teams commit resources.
• Earlier visibility into regulatory gaps: Surfaces the specific requirements and gaps most likely to slow down a submission and helps teams understand their potential severity.
• Greater predictability: Provides visibility into anticipated regulatory response windows, risks, and areas of uncertainty so teams can better plan for what lies ahead.
• Source-linked intelligence: Traces answers to the underlying regulations, guidance, and laws so regulatory professionals can verify the basis for an assessment.
• AI with human oversight: Uses Rimsys AI and Market Manager Agents to accelerate complex regulatory research while keeping regulatory professionals in control of review and validation.
• Connected planning and execution: Complements RIM, connecting market-entry decisions with the registrations, submissions, regulatory changes, and ongoing compliance required to execute them.

“Regulatory knowledge has traditionally been highly dependent on individual expertise and market-by-market research,” said James Gianoutsos, Founder and CEO of Rimsys. “Market Access gives companies greater predictability before they make a market investment. Teams can understand whether an opportunity is worth pursuing, what it will take to enter, where regulatory challenges are likely to emerge, and what uncertainty remains. And because every answer is tied to its regulatory source, experts can verify the recommendation rather than simply trust the AI.”

Market Access is powered by Rimsys AI, which works from a curated regulatory corpus spanning more than 200 markets, not the open web. Its Market Manager Agents are AI agents with market-specific regulatory knowledge, including pathways, requirements, and documentation, that support market assessments and global launch planning. The product is also designed to acknowledge areas where reviewer interpretation and expert judgment can affect regulatory outcomes rather than presenting those outcomes as more predictable than they are.

Market Access expands the Rimsys product portfolio from regulatory execution into market planning. Market Access helps regulatory and commercial leaders determine where to compete, while RIM manages the registrations, submissions, regulatory changes, product data, and ongoing compliance required to enter and remain in those markets. Together, they turn regulatory intelligence into coordinated action, helping regulatory teams accomplish more in every hour while giving business leaders greater visibility into opportunities, risk, and the work required to protect and grow revenue.

Beta Availability

Market Access will be available in beta beginning September 1, 2026. During the beta period, Rimsys will continue validating product capabilities and refining workflows ahead of broader commercial availability.

Organizations interested in learning more about Market Access or participating in the beta program can visit rimsys.io/products/market-access.

About Rimsys

Rimsys is the heart of regulatory operations, connecting AI-native market planning with AI-embedded regulatory execution, giving medtech manufacturers one living system from market-entry decision to execution.

Rimsys Market Access is the planning layer, answering not just whether a market can be entered, but whether it should be, returning classification, pathway, timeline, and cost before a team commits budget or resources to finding out. Rimsys RIM is the execution layer, managing registrations, submissions, regulatory changes, and compliance so teams can act on that plan with confidence.

Trusted by 6 of the top 12 global MedTech manufacturers and certified to ISO 27001 and SOC 2, with ISO 42001 certification for AI management systems underway, Rimsys keeps regulatory intelligence, product data, approvals, and change management continuously connected so teams can enter new markets with speed and assurance. Learn more at rimsys.io.