ISO 13485: Simplified Compliance for Medical Device Excellence

Prioritize Patient Safety and Product Quality with Qualityze ISO 13485-Compliant QMS Software

Request Demo

What is ISO 13485?

ISO 13485 is the globally recognized standard for Quality Management Systems (QMS) in the medical device industry. It defines the requirements for organizations involved in the design, development, production, installation, and servicing of medical devices and related services.

With a strong focus on safety, effectiveness, and regulatory compliance, ISO 13485 ensures that organizations uphold the highest standards of quality in delivering safe medical devices to market.

Video

Benefits of ISO 13485-Compliant QMS Software

Using ISO 13485-compliant Quality Management System (QMS) software, like Qualityze AI-powered eQMS, unlocks a wealth of benefits, transforming the way medical device organizations ensure safety, quality, and compliance:

Regulatory Compliance

Align seamlessly with ISO 13485 standards and regulatory requirements, ensuring adherence to legal obligations in the highly regulated medical device industry.

Enhanced Quality Control & Product Quality

Implement best practices to maintain strict quality oversight across all processes, reducing defects, recalls, and non-conformities while delivering superior products and boosting reliability.

Increased Customer Satisfaction

Achieve and exceed customer expectations with a customer-focused approach that strengthens trust and loyalty.

Data-Driven Decision-Making

Leverage real-time data analytics and reporting to make informed decisions, drive improvements, and foster innovation.

Continuous Improvement

Foster a culture of agility and responsiveness, adapting to evolving market needs while maintaining a competitive edge.

Audit Preparedness

Simplify audits with centralized documentation, easy data retrieval, and streamlined compliance tracking to ensure readiness and smooth certification processes.

Which Qualityze System supports the elements of ISO 13485

Qualityze EQMS software is designed to help an organization to comply with ISO 13485 standards. The following matrix will provide essential information for you to understand how Qualityze Solution can help you:

Requirements Section	Qualityze Modules
Quality Management System (QMS) This section outlines the general requirements for establishing, documenting, implementing, and maintaining a QMS that complies with ISO 13485.	Document Management Change Management Audit Management Training Management NC Management CAPA Management Complaints Management Supplier Quality Management
Management Responsibility This section focuses on the responsibilities of top management, including their commitment to the QMS, establishment of a quality policy, and communication of quality objectives.	Document Management Change Management Audit Management Training Management Dashboards & Reports
Resource Management It covers the allocation of resources, including human resources, infrastructure, and work environments, to support the QMS effectively.	Document Management Change Management Training Management
Product Realization This section delves into the processes related to product development, design, and manufacturing, emphasizing the need for risk management and validation activities.	Document Management Change Management Risk Management
Measurement, Analysis, and Improvement This section details the requirements for monitoring and measuring processes and products, conducting analysis, and implementing corrective and preventive actions to enhance the QMS continuously.	Document Management Audit Management NC Management CAPA Management Complaints Management Training Management Change Management Dashboard & Reports