Compliance Made Simple with Audit Ready
Transform compliance auditing with AI-powered regulatory standard analysis. Upload your standards and get detailed, requirement-by-requirement, compliance assessments within Matrix Req.
How the Audit Ready Works
Three simple steps to transform your compliance auditing process
Powerful Features for Complete Compliance
From document upload to final report, the Audit Ready streamlines every step of your compliance audit process with cutting-edge AI technology.
Stepwise Evaluation
Get detailed, requirement-by-requirement assessments with individual Pass/Fail/Not Applicable results and confidence levels.
Focus your analysis on priority requirements and relevant content subsets for targeted, efficient compliance audits.
Automatic preliminary assessment of requirement applicability with manual override capabilities for full control.
Understand the reasoning behind every AI assessment with clear explanations, referenced documents, and transparent logic patterns.
Audit Trail & Evidence
Complete transparency with linked documents and evidence for every compliance decision, ensuring full auditability.
Export detailed reports and integrate results directly into your QMS for seamless operational workflows.
Track compliance evolution over time with comprehensive history, comparisons, and trend analysis for continuous improvement.
See exactly which items and documents prove compliance status. Full auditability for regulatory review and management reporting.
Why Medical Device Companies Choose Regulatory Checker
Transform your compliance process with measurable improvements in speed, accuracy, and regulatory readiness.
Future-proof your audits
Future audits by notified bodies and regulatory authorities will increasingly be conducted by AI agents trained to detect even the smallest errors. Ensure your company is prepared by integrating Audit Ready from the very start of the development process.
Today marks the dawn of the AI era at the FDA with the release of Elsa. The agency is already using Elsa to accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets. The agency has plans to integrate more AI in different processes, such as data processing and generative-AI functions to further support the FDA’s mission.
FDA press release, June 2, 2025
FAQ
Integrating Audit Ready into your regulatory operations offers significant strategic and operational advantages. It allows your organization to save time by reducing the effort required for repetitive and time-consuming tasks, while enabling a more proactive approach to evolving regulatory standards. By facilitating the early identification and management of potential compliance risks, the tool helps minimize human error and oversight, ultimately improving the reliability of regulatory assessments. Furthermore, Audit Ready positions your organization to remain competitive in a future where regulatory bodies increasingly adopt AI-driven compliance verification. It also simplifies the continuous monitoring of new regulations and updated standards, ensuring that your compliance processes remain current and effective.
Your data remains the exclusive property of your organization at all times. Matrix One and its suppliers acquire no rights, title, or interest in any data you provide, whether it is input data or output data generated through our AI plugins.
Our AI solutions operate on AWS Bedrock, which adheres to Zero Data Retention (ZDR) principles. This means that any information you provide — such as device descriptions or regulatory documentation — is processed only to generate the requested output. It is not stored, logged, or used to train models. ZDR controls are implemented across our entire architecture to ensure your data remains private, compliant, and fully under your ownership.
Yes. The AI solution analyses the information and context you provide, along with any existing data, to deliver assessments and recommendations that are specifically adapted to your product, intended use, and regulatory landscape. This ensures that the resulting checklist and guidance are directly relevant and applicable to your company’s unique situation.
No. The AI does not have the capability to alter, delete, or otherwise manipulate your existing data. All AI outputs must be reviewed and validated by human experts before any action is taken, ensuring complete control and oversight remain with your organization.