Medical Device & Diagnostics

A Harmonized Framework for Managing Medical Device Quality and REGULATORY Compliance

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The AssurX Medical Device Quality Management System: Aligning Quality Objectives with Compliance Requirements

The medical device market is full of opportunities to create life-saving products that diagnose and treat patients worldwide. To meet those demands, the AssurX medical device quality management system is designed to support manufacturers in marketing safe and effective medical devices while demonstrating compliance.

Device and diagnostics manufacturers use the AssurX EQMS to bridge the gap between aligning quality processes to improve product safety, while maintaining compliance with applicable regulations.

AssurX helps enforce compliance with the following regulations and standards:

Standards for Application of Risk Management to Medical Devices

Quality Risk Management Guidance for drugs and biologics

to Support Regulatory Decisions

to Support Regulatory Decisions

Standards for Medical Device Quality Systems

to Support Regulatory Decisions

to Support Regulatory Decisions

to Support Regulatory Decisions

By proactively taking control of quality management and regulatory compliance with powerful workflow processes that form a connected, single source of truth, ventilator manufacturer Nihon Kohden OrangeMed scales with AssurX to maximize patient safety and build a strong brand.


AssurX Medical Device Quality Management System Features

Manufacturers in the medical device industry and the diagnostics industry must maintain a laser-focus on continuous quality improvement. A modern quality system using paper-based processes and siloed data is no longer viable.

AssurX CAPA Management Dashboards and Analytics

AssurX is built with robust features based on over 20 years of best practices, including:

  • A True Quality Platform

    AssurX provides all core quality and compliance processes within the software system. All pre-configured workflows are available to you from day one. Start solutions you need now, and seamlessly turn up new processes when you’re ready. No other system is easier to deploy, configure, and modify.

  • No-Code Configurability

    AssurX offers the most flexible and easy-to-use, built-in tools to create robust workflows that meet your specific process mapping with no changes to the underlying code.

  • A fully automated, centralized platform

    The AssurX platform integrates core quality processes, including complaint management, CAPA, deviations, document control, training management, audit management, and change management. Having a single repository for all quality documents enables users to quickly find the information they need.

  • Robust Analytics

    AssurX medical device EQMS provides cutting-edge analytics and reporting tools to help you identify quality issues throughout the product lifecycle. The system makes data collection and analysis easier to provide clear insights into all your quality processes.

  • Seamless eMDR (Electronic Medical Device Reporting)

    Device manufacturers and importers can submit adverse events electronically based on the applicable regulatory body (FDA, EMA, Health Canada, etc.). With AssurX, your medical device quality management system will transmit the right information for seamless and on-time reporting.

Overcome Today’s Biggest Challenges for the Medical Device Industry

AssurX medical device quality management system accelerates your quality oversight to correct issues faster and implement preventive measures to prevent recurrence. Maintain a risk-based, proactive posture for efficient problem resolution.

Increased Efficiency

AssurX increases efficiency by integrating processes to close the loop on quality issue faster and confidently. Launch CAPAs at any point in the quality chain.

Quality Aligned with Compliance

AssurX makes it easier for your teams to participate in compliance efforts by incorporating regulatory requirements in your system. Configure the system to your organization’s unique compliance demands.

Controls for HIPAA

Electronic PHI is accessible only to those who are allowed to see it. AssurX QMS software gives you the capability to set strict permission rights and shield unauthorized users from records that hold PHI.

Greater Control of Nonconformance Process

AssurX provides a dynamic process for identifying, evaluating, documenting and disposition of non-conforming product as required per FDA 21 CFR 820 and ISO13485. Common terminology, failure codes, and escalation rules enable medical device and diagnostics manufacturers to identify and investigate the root cause of the issue diligently, demonstrate control of the non-conforming product, and use non-conformance data to help improve product quality at the design stage.

AssurX Complaint Management Software is a robust system designed to document, review, and report applicable adverse events to the FDA and other international bodies.

AssurX: Connected Quality and Validated Compliance

AssurX provides expert technical and program management oversight for customer deployments around the globe. We employ a structured implementation process, providing a consistent method for architecture design.

AssurX: Quality & Compliance Systems for Every Enterprise

AssurX has been serving the medical device and diagnostics industry for more than two decades. Companies worldwide turn to us for help in reducing regulatory burden by automating quality processes while also demonstrating compliance.

We can help you establish a new medical device quality management system or improve your existing system. Using unconnected ERP, PLM, and other enterprise applications? We can integrate them for a holistic approach to compliance and optimal usage.

One Platform. Every Solution.

Seamlessly integrate all quality management and regulatory compliance management processes with one software system. AssurX provides all core quality and compliance processes within the software system, eliminating the need to budget for and install individual quality “modules.” Pre-configured workflows are available to you from day one.

First, implement the solutions you need now, then seamlessly connect more as you are ready. No other system is easier to deploy, configure, and modify.

Audit Management

CAPA Management

Calibration Management

Change Management

Complaint Management

Customer Quality Management

Deviation Management

Document Management

EHS Incident Management

Nonconformance Management

Quality Management Review

Risk Management

Supplier Quality Management

Training Management

Validation Management Solution