ISO 13485 – Medical Devices Quality Management
About the Service
ISO 13485 is an internationally recognized Quality Management System standard specifically designed for organizations involved in the design, production, installation, and servicing of medical devices. It helps ensure consistent product quality, regulatory compliance, patient safety, and effective risk management throughout the medical device lifecycle.
Service Details
Medical Device Quality Management System (MDQMS) Implementation
Gap Analysis and Compliance Assessment
Quality Policy and Objective Development
Medical Device Risk Management Support
QMS Documentation and Record Preparation
Regulatory Requirements and Compliance Evaluation
Design and Development Control Implementation
Supplier Quality Management and Evaluation
Employee Training and Quality Awareness Programs
Internal Audit Planning and Execution
Certification Audit Preparation and Coordination
Continual Improvement and Compliance Support
Add-Ons
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Key Performance Indicators (KPIs)
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