ISO13485
We had passed Medical Device Management System Certificate ISO13485 in 2022, and we run well under this Management System.
ISO 13485:2016 (full title: Medical devices — Quality management systems — Requirements for regulatory purposes) is the international specialized quality management system (QMS) standard for the medical device industry.
Here are some Key Basics about this standard,
Published by: International Organization for Standardization (ISO)
Current effective version: ISO 13485:2016 (3rd edition, published 2016)
Standalone standard: It is not just a sector-specific adaptation of ISO 9001, but a distinct, regulatory-focused QMS.
The Core Purpose are
To provide a framework for organizations to:
Demonstrate their ability to consistently provide safe and effective medical devices
Meet customer requirements and stringent regulatory obligations (e.g., EU MDR, FDA QSR, Health Canada rules)
Emphasize risk management, regulatory compliance, traceability, and patient safety throughout the product lifecycle
