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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 monitor, manage centrally, and improve their quality and regulatory compliance-related processes across all operations and product lifecycle.

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

Also, AssurX is designed to comply with the 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 successfully managing 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.

“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

Enterprise-Wide Quality Management Made for Medical Device Compliance

Single Platform

One seamlessly connected solution to improve quality, ensure compliance, manage risk, and streamline workflow.

COMPLIANCE BUILT-IN

Every solution is 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.

COMPLETE TRANSPARENCY

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

THE EFFICIENT MANAGER

Manage operations while detecting, correcting, and preventing potential issues.

EFFORTLESS STABILITY

Simple to deploy, configure, use and modify.

COMPLETE ANALYTICS

Powerful real-time trending and analytical tools.

SERVICE DELIVERED

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

Product Overview

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

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Customer Testimonial

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

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Case Study

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

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

Quality Management Built for Medical Device Regulatory Compliance

AssurX quality management system software is designed to support the FDA and EU MDR regulated medical device manufacturing industry requirements and standards. 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.

By utilizing 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 of regulatory requirements.

AssurX Quality Management System Software Features

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.

Compliance-Ready

Designed with the 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

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 “lockout” 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

Audit Trail, Electronic Signatures

Complaints Management

Audit Management

Manufacturing Quality Management

Training Management

Regulatory Reporting

Electronic Medical Device Reporting (eMDR)

Pre-Configured Medwatch 3500A Process

Supplier Quality Management (SQM)

FDA Compliance

Validation

EU MDR MIR Submission Automation

CAPA Management

Document Management

Change Management

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

Corrective And Preventive Actions (CAPA) Management Solution

The AssurX CAPA solution can effectively manage 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 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.

View AssurX CAPA Management Software Solution.

“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

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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

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“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.

View AssurX Manufacturing Quality Management Solution.

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

Angiotech Selects AssurX Quality Management Software

Change Management for Medical Device Manufacturing

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 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 are 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 the organization’s changes.

View AssurX Change Management Solution or watch the On-Demand Demo now.

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Document Management Software for Medical Device Industry

The AssurX document management solution provides integrated, easy and effective management of controlled content throughout its lifecycle—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 the use of erroneous and outdated procedures, and demonstrate regulatory compliance to inspectors.

View AssurX Document Management Solution or watch the On-Demand Demo now.

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Training Management Software for Medical Device Industry

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 is always effectively trained for the job, all training is documented correctly, and training histories are accessible, auditable, and correctly reported when necessary.

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Regulatory Reporting for Medical Device Manufacturing

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 every complaint’s reportability 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.

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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

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Pre-Configured MedWatch 3500A Process

The entire MedWatch 3500A process is pre-built and ready to use out of the box. 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 it to the FDA. For medical device 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.

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EU MDR MIR Submission Automation

AssurX software enables reporting compliance for medical device manufacturers under the European Union Medical Device Regulation (EU MDR). EU MDR addresses the European Union Medical Device Regulation (EU MDR), reporting compliance with agility and integrity. AssurX offers the Manufacturer Incident Report (MIR) for post-market incident submissions 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 published by the European Commission.

View AssurX EU MDR MIR Submission Solution.

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“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 Medical Device company selects AssurX QMS

FDA Compliance Management

AssurX boasts mature compliance management capabilities with extensive audit trails, security controls, and electronic signature/records functionality that meet or exceed 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, audits, etc. In contrast, a state of control and proof of compliance is maintained continuously in a central, accessible system.

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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. We get your solution working fast and smoothly with AssurX’s regulated industry experts. We offer professional deployment services, mentoring programs, validation, integration services, tailored scripts, test plan assistance, go-live support, and process documentation, among many others.

View AssurX Professional Services and AssurX Validation Services.

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Quality Management & Compliance for Medical Device Manufacturing