Course Overview:
The ISO 13485 Training Course provides a comprehensive understanding of the Quality
Management System (QMS) standard for medical devices. It focuses on the specific
requirements and best practices necessary to ensure the quality and safety of medical
devices throughout their lifecycle.
Course Objectives:
Understanding its role in the medical device industry, creating a compliant Quality
Management System (QMS), conducting internal QMS audits and assessments, applying risk
principles to medical device quality, getting ready for certification and aligning with global
quality standards.
Course Contents:
Core principles for medical device quality management.
Understanding rules governing device development.
Identifying and managing device-related risks.
Ensuring safety and efficacy of medical devices.
Reviewing for ISO 13485 and regulatory compliance.
Applying theory to create effective QMS for medical devices.
Target Audiences:
This training is suitable for professionals in the medical device industry, quality managers,
regulatory affairs personnel, auditors, and individuals responsible for ensuring compliance
and quality in the production and distribution of medical devices.
