Medical Devices Quality Management System Certification

What is ISO 13485?

ISO 13485:2016 is published by the International Organization for Standardization (ISO) and focuses on quality management systems in the lifecycle of medical devices, including:

• Design and development

• Production and manufacturing

• Installation and servicing

• Storage and distribution

It is applicable to all organizations involved in one or more stages of the medical device lifecycle.

Who Needs ISO 13485 Certification?

This certification is ideal for:

• Medical device manufacturers

• Suppliers and vendors of components/materials

• Contract manufacturers and sterilization providers

• Distributors and importers

• Organizations involved in technical support and installation

Key Objectives of ISO 13485

• Ensure compliance with global regulatory standards

• Maintain product quality and safety

• Improve customer satisfaction

• Enhance risk management across operations

• Facilitate market access and certification (like CE marking)

Benefits of ISO 13485 Certification

 Regulatory Compliance
Aligns your processes with global regulations (e.g., EU MDR, US FDA).

Improved Product Quality & Safety
Reduces risks and enhances the reliability of medical devices.

Global Market Access
Essential for selling in international markets, including Europe and North America.

Operational Consistency
Standardizes your procedures, reducing errors and defects.

Risk-Based Approach
Implements proactive risk management in design and production.

 Compatibility with Other Standards
Can be integrated with ISO 9001, ISO 14001, and ISO 14971 (risk management).