RegDesk
RegDesk is a Regulatory Information Management System (RIMS) that helps medical device companies manage global regulatory submissions, product registrations, and compliance in one centralized platform. It streamlines regulatory workflows, organizes regulatory data, and provides global regulatory intelligence to help teams navigate complex requirements across multiple markets. Regulatory affairs and quality teams benefit by reducing manual work, improving submission accuracy, and accelerating time to market.
Our capabilities are as follows:
• AI Application Builder
• Regulatory Intelligence
• Change Assessment
• Standards Management
• Country-Specific Templates
• Distributor Collaboration
• AI Document Management
• Tracking & Reporting
• Alerts and Notification
• Product Management
• Claims Management
• EUDAMED
For more information, visit our website.
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SAI360
The most powerful, agile approach to risk management. The decisions you make today can help mitigate the risks you may encounter tomorrow. SAI360 is cloud-first software and modern ethics and compliance learning content designed to help your organization effectively navigate risk with a flexible, agile approach. Intelligent solutions, global expertise all in one award-winning platform.
Solution configurability, extensible data model with configurable UI/forms, fields, relationships to extend solutions. Process modeling, easily modify or create new processes to automate and streamline risk, compliance, and audit activities. Data visualization and analysis, many out of the box and easy to configure dashboards to visualize and analyze data. Learning and best practice content – preloaded frameworks, control libraries, and regulatory content along with values-based ethics and compliance learning content. System integration – Integration framework with APIs and other protocols.
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meddevo
Discover a new way to manage the technical documentation of your medical devices with meddevo, a cloud-based tool crafted for the medtech industry.
Seamless Digitization: Completely transform and automate your regulatory affairs process, ensuring you're always aligned with international standards, including EU-MDR, EU-IVDR, and ANVISA.
User-friendly Experience: Using meddevo is as straightforward as filling out an online form. No steep learning curve, ensuring a smooth onboarding for your team.
Effortless Integration: Import and export data with ease, making integration into your current systems straightforward.
Top-tier Security: Hosted on the robust AWS platform, meddevo prioritizes your data's security. Activate 2-Factor Authentication (2FA) for an added layer of protection.
Unrestricted Trial: Experience all that meddevo offers during the free trial, ensuring a comprehensive understanding of its capabilities.
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Adherent
Adherent is an agentic AI product compliance platform designed to help companies keep products compliant across global markets. Formerly Compliance & Risks, the platform helps teams monitor regulatory change, assess applicability, identify requirements, prioritize business risk, and manage compliance workflows. Adherent uses AI agents to reduce manual effort by monitoring regulations, mapping requirements to products, extracting obligations, and surfacing the risks that need attention first. The platform combines enterprise-grade AI with human-verified regulatory intelligence built from nearly 25 years of compliance expertise. Ari, Adherent’s AI product compliance assistant, acts as a digital teammate that executes compliance workflows while experts focus on strategic decisions. Adherent helps regulated enterprises turn product compliance from a roadblock into a growth enabler with explainable, auditable, and trusted compliance intelligence.
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