Compliance-Ready EQMS for Medical Devices
Discover how a cloud-based EQMS Simplifies Medical Device Development by streamlining non-conformance management, CAPA, document management and complaint management with ease. From proactive risk management to adverse event reporting, it empowers you to manage compliance challenges with advanced features and security controls. Using AI Powered EQMS in the Medical Device Industry reflects the true commitment to excellence, innovation, and patient safety.
Master ISO 13485, FDA 21 CFR Part 820, and MDR Requirements in One Powerful Platform
In the medical devices industry, precision and quality are non-negotiable since they deliver a promise to protect lives with every device. Qualityze EQMS provides a purpose-built solution to help you maintain rigorous quality standards while navigating evolving regulations like FDA, MDR, and ISO 14971. Whether you’re managing supplier quality, CAPA, non-conformance, complaints management, or device interoperability, our system provides you with robust in-built tools to take care of everything you need to stay compliant and efficient. Advanced risk management, real-time monitoring, eSignature validation, version control, and seamless integration are the capabilities to name a few. Qualityze empowers you to deliver safer, more reliable devices while driving continuous improvement in every aspect of your operations. Discover how.
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The Qualityze Difference Empowers You To:
Enhance Patient Safety with In-Built Risk Management
Leverage configurable workflows to align risk management capabilities with ISO 14971. It helps proactively identify, assess, and mitigate risks throughout production. Our solution integrates risk thresholds, evaluation criteria, and response mechanisms to ensure patient safety and regulatory compliance.
Proactively Manage Post-Market Surveillance (PMS)
Stay ahead in regulatory reporting with centralized post-market surveillance tools. Our EQMS facilitates adverse event reporting, recall management, and trend analysis, ensuring compliance with FDA and EU vigilance requirements to maintain product safety and quality.
Optimize Supply Chain Quality and Traceability
Ensure supplier compliance and traceability across the medical device supply chain with our integrated supplier quality module. Manage approved supplier lists, scorecards, and supplier risks while complying with global UDI mandates for enhanced traceability.
Streamline Regulatory Compliance Across Global Markets
Our EQMS simplifies adherence to complex regulations such as FDA 21 CFR Part 820, EU MDR/IVDR, and ISO 13485. With pre-configured workflows, automated reporting, and real-time tracking, it ensures seamless compliance across diverse regulatory landscapes while reducing the burden of documentation.
Secure Device Interoperability and Cybersecurity
Address the growing challenges of device connectivity with built-in security controls and compliance workflows for IEC 62304 and ISO/IEC 27001. Our solution supports secure data exchange and real-time monitoring to mitigate cybersecurity risks.
Maintain Comprehensive Adverse Event Reporting Systems
Easily capture, track, and report adverse events with our integrated EQMS, ensuring compliance with FDA eMDR and EU vigilance system requirements. Our solution helps generate HL7 compliant xml files for eMDR submissions. Our pre-defined workflows streamline investigations and prevent recurrence effectively.
| Standard/Regulation | Description |
|---|---|
| ISO Standards | |
| ISO 13485 | Quality Management Systems for Medical Devices |
| ISO 14971 | Application of Risk Management to Medical Devices |
| ISO 9001 | General Quality Management System Requirements |
| ISO 31000 | Risk Management Principles and Guidelines |
| FDA Regulations | |
| 21 CFR Part 11 | Electronic Records and Electronic Signatures |
| 21 CFR Part 820 | Quality System Regulation for Medical Devices |
| 21 CFR Part 803 | Medical Device Reporting (MDR) |
| 21 CFR Part 806 | Medical Device Corrections and Removals |
| 21 CFR Part 210/211 | Current Good Manufacturing Practice (cGMP) for Drugs and Certain Devices |
| GxP Guidelines | |
| GMP | Good Manufacturing Practices |
| GLP | Good Laboratory Practices |
| GCP | Good Clinical Practices |
| Other MDR Regulations | |
| EU MDR | Regulation (EU) 2017/745 for Medical Devices |
| MHRA | Medicines and Healthcare Products Regulatory Agency - UK |
| PRAC | Pharmacovigilance Risk Assessment Committee - EU |
| PMDA | Pharmaceuticals and Medical Devices Agency - Japan |
| Health Canada | Canadian Regulatory Authority for Medical Devices and Drugs |
| TGA | Therapeutic Goods Administration - Australia |
| Pharmacovigilance Standards | |
| ICH E2E | Pharmacovigilance Planning |
| ISO 62366 | Application of Usability Engineering to Medical Devices |
| WHO Guidelines | Safety Monitoring of Medical Devices |
| EMA GVP | Good Pharmacovigilance Practices: Risk Management and Safety Reporting |
| Other Key Standards | |
| IEC 60601 Series | Standards for the Safety and Performance of Electrical Medical Devices |
| IEC 62304 | Medical Device Software Lifecycle Processes |
| HL7 Standards | Health Level 7 Interoperability Standards for Electronic Health Data Exchange |
Reasons to choose Qualityze EQMS for Medical Devices Industry
Choosing Qualityze Enterprise Quality Management Solution will be a beneficial decision for the Medical Devices industry because it has
User-Friendly Interface
Simplifies usability with an intuitive design, requiring no technical expertise.Seamless Integration
Fits perfectly with your existing systems to enhance operational efficiency.Cloud-Based Platform
Provides secure, flexible, and anywhere-accessible data management.Automated Upgrades
Keeps you up-to-date effortlessly with automatic version upgrades.Configurable workflows and Fields
Adapts to your unique business processes with configurable options.Low Implementation Costs
Delivers a cost-effective solution without compromising on performance.Minimal Maintenance Needs
Eliminates hardware dependencies, offering easy access from any location.Flexibility and Security
Combines robust security with cloud-based flexibility to meet dynamic needs.AI-Powered Assistant
Offers intelligent support for proactive decision-making and streamlined workflows.The Start of Something Amazing.
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