Quality assurance is paramount in medical device manufacturing. This article examines the critical standards and practices that ensure patient safety and regulatory compliance.
ISO 13485: Medical Devices Quality Management
ISO 13485 is the international standard for quality management systems in medical device manufacturing. It provides a framework for organizations to demonstrate their ability to provide medical devices that consistently meet customer and regulatory requirements.
FDA Regulations
In the United States, the Food and Drug Administration (FDA) regulates medical devices to ensure their safety and effectiveness. Manufacturers must comply with FDA regulations, including premarket approval processes and post-market surveillance.
CE Marking
For the European market, CE marking indicates that a medical device meets EU safety, health, and environmental protection requirements. This certification is essential for market access in European countries.