ISO 13485:2016
MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM
One of the medical device industry’s most widely used international standards for quality management is ISO 13485. The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations, and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements.
