How RegDesk is Reinventing Regulatory Change Control and Expanding the Power of AI
Global regulatory change never stops. Requirements evolve, documentation grows, and every product update can have ripple effects across dozens of markets. For regulatory teams, that means the constant adaptation of assessing changes, revising submissions, and maintaining compliance while the rules keep moving.
At RegDesk, we believe that regulatory teams shouldn’t have to choose between speed and accuracy. Our latest platform release continues our mission to simplify global compliance through automation and intelligence helping our customers plan smarter, build faster, track progress, and maintain compliance confidently.
This update introduces three key advancements:
- A reimagined Change Assessment experience that transforms how regulatory teams manage product changes globally.
- An expanded RegDesk AI Translation tool that helps teams understand and act on regulatory content faster than ever.
- New RoHS and REACH requirements added to Reg Intel, deepening visibility into global chemical and environmental regulations.
Together, these updates represent an important step forward in the RegDesk journey: embedding intelligence deeper into every phase of the regulatory process.
Reinventing Regulatory Change Control
When regulations change or products are updated, teams must determine what those changes mean for their existing approvals. Historically, that process has been complex, manual, and fragmented across multiple systems and spreadsheets with review cycles scattered across teams and regions.
The upgraded Change Assessment Module in RegDesk changes that entirely.
Built around a four-stage workflow; Start Assessment, Task Strategy, Approve, and Create Workflow the redesigned Change Assessment experience connects every step of the process, ensuring full traceability from impact analysis to implementation.
Here’s what that means for regulatory professionals:
- Assess once, act everywhere: Each change is evaluated independently, then consolidated into a single global strategy.
- Smarter automation: The system automatically identifies relevant countries based on existing tracking data and pre-populates them into the workflow.
- Collaborate confidently: Assign responsibilities per country or region while maintaining centralized oversight.
- Stay audit-ready: Every action, document, and approval is automatically captured in one consistent, compliant record.
Instead of spending days coordinating updates across regions, teams can now manage the entire process in a single, unified workflow. The result is faster execution, fewer errors, and greater confidence in compliance outcomes.
“The redesigned Change Assessment experience is about confidence,” said Priya Paul, CEO of RegDesk. “It helps regulatory teams focus on strategy, not process knowing every change is tracked, approved, and compliant across every market.”
This is not just a feature update, it is a rethinking of how global change control should work. By integrating automation, structure, and visibility into one cohesive process, RegDesk is helping regulatory teams move faster while reducing risk.
Expanding the Power of RegDesk AI
The second major enhancement in this release extends our existing strategic AI capabilities with AI-powered document translation capability, integrated seamlessly into the regulatory analysts workflow within RegDesk to further reduce time to compliance.
The AI Translation Tool builds on RegDesk’s growing portfolio of AI capabilities from AI Submission and AI Form Builder to upcoming advancements in AI Search and Document Comparison to allow medical device manufacturers to get to market faster. This latest expansion brings intelligent automation into the earliest stages of regulatory planning, allowing users to get a regulatory lay of land globally, instantly.
With the new AI Translation tool, users can instantly translate regulatory documents, guidance, and standards into over 50 languages directly within RegDesk. The translation preserves the original layout and formatting, enabling seamless use in reviews, assessments, and submissions.
This means:
- No more manual translation or copy-paste workflows.
- Instant context for global regulations, guidance, and technical documents.
- Consistent quality and accuracy across all translations, with structure and metadata preserved.
- Enhanced collaboration across global teams that rely on documents in multiple languages.
By embedding this capability directly into the RegDesk platform, users can move from research to action in seconds to review and compare requirements across markets without relying on external tools or translation vendors.
“AI Translation reflects our long-term vision to weave intelligence throughout every phase of regulatory work,” said Jodi (Director, Regulatory Affairs). “It’s part of an expanding AI foundation that’s already transforming how our customers plan and execute globally.”
AI Translation is more than an upgrade, it’s a signal of what’s coming next. This capability marks the continued expansion of RegDesk AI, a connected intelligence layer that accelerates global market readiness from planning through post-approval maintenance.
Future releases will continue to build on this foundation, introducing even deeper AI features such as document comparison, search, and predictive change impact analysis.
Sharper Regulatory Intelligence with RoHS and REACH
The third component of this release expands RegDesk’s intelligence layer adding RoHS (Restriction of Hazardous Substances) and REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) requirements to Reg Intel.
These new additions, among other related topics, provide country-specific insights into chemical and substance regulations, helping regulatory teams integrate environmental and material compliance considerations alongside product approvals.
With this update, users can:
- Access RoHS and REACH guidance within Reg Intel alongside device and labeling regulations.
- Understand market-specific expectations around hazardous materials and chemical safety.
- Centralize environmental compliance research within the same platform that manages regulatory submissions.
It is a focused, data-driven enhancement, not a broad “environmental compliance” module, ensuring accuracy and transparency in how information is presented.
This update strengthens the Maintain phase of RegDesk’s value framework, giving customers a more holistic view of what’s required to keep their products compliant in an increasingly complex regulatory environment.
The Framework: Plan. Build. Track. Maintain.
At RegDesk, we organize every capability within a connected framework Plan → Build → Track → Maintain.
It’s how our customers move faster, reduce risk, and stay compliant across global markets.
- Plan Smarter: AI Translation helps teams understand global requirements instantly, in any language.
- Build Faster: Expanded Reg Intel ensures ongoing awareness of global chemical and product standards.
- Track Progress: Integrated visibility across countries, products, and families keeps teams aligned.
- Maintain Confidently: The new Change Assessment workflow brings automation and structure to regulatory change management.
This framework reflects more than a set of features, it is how RegDesk helps regulatory teams operationalize intelligence and automation to navigate change at scale.
What’s Next: The Next Step in RegDesk AI
This release is part of a long-term roadmap to expand RegDesk AI across every phase of regulatory work.
Following AI Translation, our next wave of AI capabilities including AI Document Comparison and AI Search will further simplify how teams research, assess, and respond to regulatory change.
These capabilities will build upon the same core principle: embedding AI where regulatory teams already work.
Because at RegDesk, innovation isn’t about new tools or interfaces, it’s about making regulatory work easier, faster, and more accurate for the people doing it every day.
Conclusion: The Future of Regulatory Work
RegDesk’s latest release reinforces a simple truth: compliance shouldn’t slow innovation.
With a redesigned Change Assessment workflow, an expanding suite of AI capabilities, and continuously growing regulatory intelligence, RegDesk continues to set the standard for how global regulatory teams manage complexity with confidence.
Whether you’re planning your next market entry, assessing product changes, or maintaining compliance across dozens of countries, RegDesk helps you do it all faster, smarter, and with complete confidence in every decision.
