# ISO 13485 Certificering [ISO 13485 Certificering ](https://iasiso-europe.com/dutch/iso-13485-certificering-in-nederland/)is an internationally recognized certification for quality management systems in the medical device industry. It helps organizations demonstrate their ability to consistently design, manufacture, and supply medical devices that meet customer and regulatory requirements. The certification focuses on risk management, product quality, process control, and regulatory compliance throughout the product lifecycle. It is suitable for medical device manufacturers, suppliers, and service providers. Achieving ISO 13485 Certificering enhances product reliability, improves operational efficiency, strengthens customer confidence, and supports access to international markets while ensuring a strong commitment to patient safety and quality excellence.