ISO 13484 Registration

Organizational Scope: The entity must be engaged in the manufacturing, design, or maintenance of medical electrical equipment and systems covered by ISO 13484.

Standards Compliance: The organization should demonstrate its ability to fulfill the requirements specified in ISO 13484, including aspects of quality management, safety, and performance standards for medical electrical devices.

Quality Management System (QMS): A comprehensive and effective QMS aligned with ISO 13484 principles must be in place to ensure consistent product quality and safety.

Documentation and Records: The organization must maintain thorough documentation, such as quality policies, procedures, and records, to evidence compliance and ongoing improvement initiatives.

Internal Audits and Management Review: Regular internal audits and management evaluations should be conducted to ensure compliance with standards and to identify opportunities for enhancement.

Operational Preparedness: The organization should be ready for external audits by certification bodies, demonstrating effective implementation of processes and controls.

Legal and Regulatory Compliance: All applicable legal and regulatory requirements pertaining to medical electrical equipment in the relevant regions must be adhered to by the organization.