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As you know, the medical device manufacturing vertical is highly regulated industry. The quality management system for this industry must meet regulatory requirements which mandate the manufacturers to design and develop medical devices that are safe and fit for their intended use.

ISO 13485 standard was designed to assist medical device manufacturers to develop and implement quality management systems that meet and exceed regulatory requirements. ISO 13485 is derived from the ISO 9000 family of standards set forth by International Organization for Standardization (ISO).

Qualityze Solution Information Matrix for ISO 13485

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

Requirements Section Description Qualityze Modules
Section 4: General Requirements: Quality Management System Provides requirements for the overall Quality Management System from quality manual documentation to the control of documents and records.
  • Document Management
  • Change Management
Section 5: Management Responsibility Provides requirements for Management’s role and commitment in the QMS.
  • NC/Complaints Management
  • CAPA Management
  • Change Management
  • Document Management
  • Audit Management
  • Training Management
Section 6: Resource Management Provides the guidelines for resources to perform the job competently and in safety.
  • Document Management
  • Training Management
Section 7: Product Realization Provides the guidelines for customer related processes, design and development and purchasing
  • NC/Complaints Management
  • CAPA Management
  • Document Management
  • Audit Management
Section 8: Measurement, Analysis and Improvement Gives ISO requirements on monitoring processes and improving those processes such as customer satisfaction, internal audit, control of Non-Conforming Product, Corrective and Preventive Action (CAPA) and
continual improvement
  • NC/Complaints Management
  • CAPA Management
  • Document Management
  • Audit Management
  • Dashboard & Reports
  • eQMS Suite & User Portal