Understanding the Significance of ISO 13485 Standard in Medical Devices

 In the dynamic and rapidly evolving field of medical devices, adherence to stringent quality standards is paramount. One such crucial standard that governs the quality management system for medical devices is the ISO 13485 standard. Developed by the International Organization for Standardization (ISO), the ISO 13485 standard plays a pivotal role in ensuring the safety and efficacy of medical devices worldwide.