“AssurX is the most flexible and intuitive solution on the market. It is also the most user-friendly from both the end user and administrative perspective. AssurX is 5–10 years ahead of their competitors.”

Sanofi-genzyme selects AssurX Quality Management System

Quality Management & Compliance for Medical Device Manufacturing

Managing industry best practices to drive product innovation and patient safety
AssurX medical device manufacturing quality management software (QMS) is designed to balance the complexity of global quality management and regulatory requirements while maintaining a high level of flexibility to adapt to continual industry and operational changes.  

Successful life science companies utilize AssurX’s seamlessly integrated software to centrally monitor, manage and improve their quality and regulatory compliance-related processes across all operations and product lifecycle.

AssurX software is designed to support current good manufacturing practices (CGMP) and medical device regulations including FDA 21 CFR part 820, European Union Medical Device Regulation (EU MDR), and ISO

In addition, AssurX is designed to comply with U.S. Department of Health and Human Services (HHS) and HIPAA patient privacy regulation.

AssurX platform and preconfigured solutions provide U.S. Food and Drug Administration 21 CFR Part 11 validated processes for the successful management of QMS processes including; complaints, supplier quality, document control, CAPA, change management, audits, and training

A state of control and proof of compliance is maintained continuously in one central, securely accessible system.

Enterprise-Wide Quality Management Made for Medical Device Compliance

Single Platform

One system of seamlessly connected solutions to improve quality, ensure compliance, manage risk and streamline workflow.


Every solution built for FDA, ISO and cGXP. Seamlessly integrated electronic medical device reporting.

Streamlined Activities

Automatically orchestrate and track activities, share data and communicate information to the appropriate parties.


Dashboards provide live, clear views of coordinated activities and information across all areas of the business.


Manage operations while detecting, correcting and preventing potential issues.


Simple to deploy, configure, use and modify.


Powerful real-time trending and analytical tools.


Available as either traditional OnPremise (licensed software) or OnDemand (cloud-based SaaS).

Quality Management system and Regulatory Compliance Software QMS for Medical Device Manufacturing

Product Overview

Watch this Video Overview of the AssurX Quality Management System Platform.

Customer Testimonial

Listen to What Other Medical Device Manufacturing Professionals Have to Say About AssurX.

Case Study

Learn How a Cardiac Device Manufacturer Was Able to Eliminate Over 2,400 Manual Hours Per Year Using AssurX.

“The team at AssurX was fantastic throughout the design, implementation, and launch of our QMS system.”

NXstage Medical Device Manufacturing company selects assurx for compliance management

Quality Management Built for Medical Device Regulatory Compliance

AssurX quality management system software is designed to support requirements and standards for the FDA  and EU MDR regulated medical device manufacturing industry. The solutions seamlessly integrate, creating an ironclad closed-loop system to identify, track, resolve, document and report all quality and compliance issues across every part of operations—even into the supply chain.

Using AssurX’s closed-loop quality management and software, you know immediately when an issue arises at any point of origin.  All relevant areas of your organization share the information needed to contain, evaluate and quickly resolve the problem.

Using powerful, real-time analytical tools the software helps companies identify, assess and remediate risk exposure; perform the detailed trend analysis needed to prevent quality and compliance problems and continually improve operations.

AssurX boasts mature compliance management capabilities with extensive audit trails, security controls, and electronic signature and records functionality that meets or exceeds rigorous standards regulatory requirements.

AssurX Quality Management System Software Features

AssurX delivers central control, improved compliance and business performance to regulated industries.

CAPA Integration

Automatically track, trend, resolve and document all product issues—initiated from any source, across all functional areas—before they become costly problems. Reduce or prevent quality incidents. Control costs and make better products the first time around.


Designed with flexibility to meet changing cGXP and FDA regulations, the software guides users step-by-step through the process to meet requirements. Preconfigured forms contain all pertinent information blocks required for compliance and smooth operations, dramatically reducing the risk of non-compliance. And, all records are easily accessible in one repository.

Business Intelligence

Enterprise-wide Intelligence with dashboards, KPIs and metrics. Get real-time trending with graphical dashboards and analytics that deliver instant business intelligence, accessed anywhere with an Internet connection.

Seamless eMDR

The FDA’s device reporting system offers huge potential savings in time and money—if it can be properly used. AssurX “feeds” the right information in the correct manner, for seamless FDA compatibility.


eSignatures, 21 CFR Part 11: AssurX’s solution is designed to meet or exceed this important regulation’s strict audit trail and e-data integrity requirements.

Enables HIPAA Compliance

Make certain e-data is open only to those who are allowed to see it. AssurX makes it easy to “lock out” those who aren’t authorized to view any e-data field that requires shielding.

Risk-based Quality Management

Built-in risk assessment features for critical QMS processes such as CAPA and a robust Risk Management solution helps you prioritize activities and meet ISO standards for “risk-based thinking” in quality management systems.

Simple Integration

Integrate to ERP, MES, HR, SCM, internally developed applications, databases, etc., using a robust, flexible open interface.

The AssurX platform offers an easy-to-use, flexible, integrated system of quality management solutions
that are designed for FDA and EU MDR regulated companies.

One QMS Platform Delivers Every Solution for Medical Device Manufacturing


“The system was deployed under budget and ahead of schedule.”

Abbott medical device company selects asurx for compliance management

Corrective And Preventive Actions Management

The AssurX CAPA solution can effectively manage the resolution of any issue regardless of where it originates or how many departments the problem encompasses.

It is fully integrated with other quality-related processes such as audits, nonconformance, customer complaints, and change management. Issues initiated from any department are investigated, root causes identified, corrective and preventive actions planned and implemented across operations, and then they are evaluated for effectiveness.

Medical device companies can use the AssurX system to control costs and improve their products while meeting regulatory requirements for closed-loop quality management.

“For us the benefit of using AssurX is the audit trails, electronic signatures and workflow control. Before AssurX our processes didn’t move. AssurX enables us to know who is doing what, and when they need to have it done.”

– LiseAnn Bailey, Global Cardiac
Assist Device Manufacturer

Compliant Audit Trail, Electronic Signatures

Built to ensure FDA compliance, the software incorporates audit trails and electronic signatures compliant to 21 CFR Part 11 and maintains an easy to access, secure time-stamped archive.

  • Audit trail of all MedWatch 3500 as submitted, as well as all follow-ups, modifications, and attachments
  • Query on all audit trails
  • View edits/changes in any form in the audit trail showing the before/after field values
  • View changes on entire record at once, not just individual fields
  • Electronic signatures cannot be modified, copied, transferred or deleted
  • Accommodates signature comments

Download the Complaint Management Solution Datasheet

Complaints Management

The AssurX complaints management and regulatory reporting system provide the ‘best practice’ approach for managing the entire lifecycle from event intake through investigation, root cause analysis and reporting to regulatory agencies. It features include best practice matrixes, management dashboards, and strong audit trail reports and controls.

Download the Audit Management Solution Datasheet

Audit Management

The AssurX audit management solution delivers a comprehensive audit management process and adheres to best practices for closed-loop findings, closure, task assignments, and escalation. Audits are conducted after being planned, findings are classified, and follow-up is assigned to the right area managers. After follow-up actions are addressed, a final report is issued and routed for complete closure.

“To effectively and efficiently manage a significant volume of regulatory documentation…you need a reliable and highly configurable system to meet that challenge.”


Manufacturing Quality Management (NCMR, Deviations, Issue Tracking)

Globally document, track, and resolve manufacturing related quality issues such as nonconformance, deviations, defects, incidents, exceptions, and change requests, from initiation through disposition, corrective action and change execution. This closed-loop system is fully integrated with other quality and compliance processes and follows ISO and GMP standards for best practices. Track trends, cycle times and costs to facilitate root cause analysis and improve efficiency.

“With AssurX, we have significantly improved our efficiency and productivity.”


Change Management

A flexible, central system orchestrates, tracks and documents changes across all functional areas of a business. It creates a consistent, compliant closed-loop method to process any type of change (e.g. business process, product design, documentation, etc.). Proposed changes initiated from any department are evaluated; change plans are mapped out; tasks, reviews, and approvals assigned and tracked; then approved changes are released and implemented across operations; and training programs for new materials are initiated.

With easy, full integration to other quality related processes, it keeps coordinated control over changes across the organization.

Download the Document Management Solution Datasheet

Document Management

The AssurX document management solution provides integrated, easy and effective management of controlled content throughout its life cycle—from change orders through release approval, dissemination and training. Get rapid, secure access to current and accurate documents at all times. AssurX Document Management allows businesses to improve global visibility of process changes, reduce risk and labor costs associated with use of erroneous and outdated procedures, and demonstrate regulatory compliance to inspectors.

Download the Training Management Datasheet

Training Management

Take charge of all training requirements, activities, materials/courses and histories throughout your organization. Quickly identify “who-needs-what” training even in complex, changing environments. The AssurX solution ensures your personnel are always effectively trained for the job, all training is properly documented and training histories are accessible, auditable and correctly reported when necessary.

Download the Medical Device Complaints Management and Regulatory Reporting Brochure

Regulatory Reporting

AssurX solutions follow industry standards and best practices for closed-loop quality systems for medical devices, pharmaceutical and other life science industries. The system guides the process of determining the reportability of every complaint using decision-tree processing, automating the evaluation of reporting requirements for the US FDA, Canada, European Union (EU MDR), and Australia. Automatically manage report due dates and notify assignees when reporting tasks become due or past due. Generate MedWatch 3500A and other vigilance reports in PDF format. Generate follow-up and supplemental reports based on changes to previously submitted reports.

Download the Electronic Medical Device Reporting Datasheet

Electronic Medical Device Reporting (eMDR)

AssurX eMDR provides a closed-loop, end-to-end automated reporting system without the requirement of any additional third party tools or EDI systems. Everything is built-in, ready to go. MedWatch 3500A and other vigilance reports can be generated and submitted directly from the system. The solution delivers improved on-time reporting that also substantially improves accuracy and productivity in your reporting process.

  • Control of the entire MDR reporting cycle
  • Built-in dashboards with real-time tracking for all MDR submissions
  • Complete end-to-end solution—no need for 3rd party tools or components
  • Submit 5- & 30-day MedWatch reports, follow-up reports and attachments
  • Central management of tasks with notifications, escalations, rules and reminders
  • Support for US Med Device Baseline, EU Vigilance and Canadian Med Device Reports

Download the Electronic Medical Device Reporting Datasheet

Pre-Configured MedWatch 3500A Process

The entire MedWatch 3500A process is pre-built and ready to use out of the box. Simply enter the medical device company’s manufacturing ID and general default values such as address information to get started. No additional configuration is needed—users can start using the process and submitting to the FDA. For medical devices companies, eMDR (electronic medical device reporting) is fully integrated, allowing MedWatch 3500A and other vigilance reports to be generated and submitted directly from the system.

Download the EU MDR MIR Submission Management Solution Brochure

EU MDR MIR Submission Automation

AssurX software enables reporting compliance for medical device manufacturers under European Union Medical Device Regulation (EU MDR).  Addresses the European Union Medical Device Regulation (EU MDR) reporting compliance with agility and integrity. For post-market incident submissions, AssurX offers the Manufacturer Incident Report (MIR) within the solution for efficient and compliant reporting of applicable medical device vigilance incidents. The AssurX MIR aligns business logic with the latest Manufacturer Incident Report template as published by the European Commission.

Download the Supplier Quality Management Solution Datasheet

Supplier Quality Management (SQM)

AssurX’s SQM solution offers instant collaboration and visibility across your supplier network to vastly improve product quality. No matter the number or location of your suppliers and contract manufacturers, SQM lets you quickly detect, inspect, track, trend and contain supplier related quality issues quickly and correct them before they become bigger issues.

“We felt AssurX’s ease of configurability allowed us to continue to adapt our processes and solutions to Genzyme’s increasing product portfolio, facilities and international markets.”

Sanofi-genzyme selects AssurX Quality Management System

FDA Compliance

AssurX boasts mature compliance management capabilities with extensive audit trails, security controls and electronic signature/records functionality that meet or exceeds rigorous regulatory requirements. The system is even flexible enough to keep you in compliance with changing cGXP requirements. AssurX’s preconfigured closed-loop solutions deliver efficient processes to manage complaints, supplier quality, document control, CAPA, change, and audits, etc., while a state of control and proof of compliance is maintained continuously, in a central, accessible system.

Download the Validation Management Services Datasheet

Validation & Professional Services

AssurX offers an array of documentation, and pre-configured validation scripts and templates to assist in your implementation. IQ/OQ and process qualification procedures provide a starting point for alignment with your computer software master validation plan. To get your solution working fast and smoothly, AssurX’s regulated industry experts offer professional deployment services, mentoring programs, validation, integration services, tailored scripts, test plan assistance, go-live support, and process documentation, among many others.