Medical Device & Diagnostics

A HARMONIZED FRAMEWORK FOR MANAGING MEDICAL DEVICE QUALITY AND REGULATORY COMPLIANCE

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. AssurX medical device quality management system is designed to support manufacturers in marketing safe and effective medical devices. Additionally, it demonstrates compliance to meet those demands.

Device and diagnostics manufacturers use the AssurX EQMS to bridge the gap between aligning quality processes to improve product safety. They also maintain medical device compliance with applicable regulations.

TRUSTED BY

AssurX medical device quality management software 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

Ventilator manufacturer Nihon Kohden OrangeMed proactively takes control of quality management and regulatory compliance with powerful workflow processes that form a connected, single source of truth. They scale 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. Managing and controlling large volumes of documents, such as SOPs , training records, and quality manuals, is critical. A modern quality system using paper-based processes and siloed data is no longer viable.

Medical device QMS software facilitates compliance with stringent regulations by providing a framework for standardizing processes and maintaining proper documentation. Medical device compliance software automates document control, so teams use current and approved documents. This allows easier updates and audits for transparency and consistency.

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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 medical device 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. These workflows can meet your specific process mapping with no changes to the underlying code.

  • A fully automated, centralized platform

    The AssurX medical device quality management system integrates core quality processes. It includes 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.

FEATURED SOLUTION

AssurX Design Control solution ensures medical devices that are designed and manufactured meet specified compliance requirements and that necessary design control phases are addressed according to the intended use and purpose.

AssurX Design Control Software Brochure

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 issues faster and more confidently. Launch CAPAs at any point in the quality chain. Our medical device QMS software can integrate risk management into all quality processes, ensuring a consistent approach to risk across the organization.

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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 medical device regulatory compliance demands. Our medical device compliance software helps you to be audit-ready. Its robust features provide comprehensive tracking and documentation capabilities.

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.

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Greater Control of Nonconformance Process

AssurX medical device manufacturing software provides a dynamic process for identifying, evaluating, documenting and disposition of non-conforming products 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. They also 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. Our medical device compliance software offers robust data analysis and reporting capabilities. Metrics KPIs allow our customers to make informed decisions based on real-time data.

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 within our medical device quality management system.

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 medical device regulatory compliance.

Our experts built an eQMS that can scale with your organization as it grows. Businesses need to shift and adapt frequently in the medical industry to stay competitive and our system allows that.

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 medical device regulatory compliance and optimal usage.

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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. This eliminates the need to budget for and install individual quality “modules.” Pre-configured workflows are available to you from day one with our quality management software.

AssurX is an exceptional platform that facilitates transitioning from a labor-intensive, paper-based process to a streamlined electronic system. By adopting AssurX, you can embrace the enhanced organization that comes with digitizing documents and files.

With AssurX, everything is easily searchable, allowing for quick retrieval and efficient information management. This level of organization drastically improves accessibility to records, reducing the time wasted.

First, implement the solutions you need now, then seamlessly connect more as you are ready. No other quality management system is easier to deploy, configure, and modify. Integrations with other software solutions make AssurX invaluable. Your data won’t be stuck in several silos. Instead, you’ll have one unified system for optimal efficiency.

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