ISO 13485:2016 specifies requirements for a Quality Management System specific to the medical device industry. It ensures that medical devices consistently meet regulatory and customer requirements.

The standard focuses on risk management, product safety, and regulatory compliance throughout the product lifecycle. Implementing ISO 13485 improves product quality and patient safety.

Advantages:

• Ensures regulatory compliance
• Improves device safety
• Enhances quality control
• Builds customer confidence