Stay Ahead with Regulatory Change Management
Learn MoreRevolutionize the way you handle change assessment. Built around a unified four-stage workflow; Start Assessment, Task Strategy, Approve, and Create Workflow our Change Assessment experience connects every step of the process, ensuring full traceability from impact analysis to implementation. We integrate automation, structure, and visibility into one cohesive process, allowing regulatory teams to move faster while reducing risk.
Real-Time Regulatory Monitoring
Eliminate the need for manual tracking with RegDesk’s real-time regulatory monitoring. Teams can track updates relevant to their products and markets, getting rid of inefficiencies and ensuring timely preparation for any changes.
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AI-Driven Impact Analysis
Take a new approach to compliance and risk management with our revolutionary technologies. With RegDesk’s impact analysis, teams can adapt internal processes, policies, and controls to identify potential risks from regulatory changes to avoid costly delays.
Clear Visibility into Regulatory Status
Ensure global compliance and manage the regulatory status of your devices. To manage the regulatory compliance of devices across multiple markets, our technology creates clear visibility into changes by product, country, and SKU to make tracking easier than ever before.
Instant Access to Global
Regulatory Intelligence
Staying up-to-date with regulatory changes is crucial when ensuring compliance. At RegDesk our regulatory change management solution focuses on global regulatory intelligence, so teams can pivot quickly and react to shifts in the regulatory landscape more effectively.
Automated Compliance Workflows
Streamlined processes ensure better organization and efficiency to create compliance during all aspects of regulatory change management.
You can:
- Assess once, act everywhere: Each change is evaluated independently, then consolidated into a single global strategy.
- Automate Intelligently: 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.
Stay on Top of Regulatory Changes
Let us help you reduce risks and streamline compliance with our efficient technology.
Get a DemoFrequently Asked Questions
What is regulatory change management?
Regulatory change management is the process of assessing, tracking and implementing changes to products over time. A critical obligation for manufacturers is to ensure a global regulatory assessment is completed before any change is implemented, and if required a submission to regulatory agencies is executed and approved before the modified product is released for sale.
What is regulatory intelligence?
Regulatory intelligence involves gathering and analyzing global regulatory updates to provide insights into regulatory trends and requirements. It helps teams understand and anticipate changes, empowering them to stay compliant and reduce risks in the regulatory landscape. Having a process in place for monitoring regulation changes, performing an impact assessment, and taking action where needed is a key quality system element reviewed by auditors. Being able to effectively demonstrate you understand the current regulation status and are conforming to those requirements is essential for all markets where product is distributed.
How often do regulations change for medical devices?
Regulations for medical devices can change frequently, with updates occurring at various intervals, from months to years, depending on the region and regulatory framework. For example, the EU MDR and IVDR have undergone significant updates, and manufacturers must stay proactive in tracking and adapting to these changes.
