What Are ISO 13485 Requirements For Medical Device Industry?
Medical products travel across the world. Blood pressure monitors made in Asia are sold in Europe. Similarly, blood glucose monitors travel thousands of kilometers to reach buyers. How do buyers rely on products imported from a distant country? It is where ISO 13485 requirements help medical device manufacturers. Buyers invest only in ISO-certified products. What are […]
What Are ISO 13485 Medical Devices?
ISO 13485 medical devices are products certified by the International Organization for Standardization. The certificate shows that the devices are reliable and that they are designed and manufactured following established rules and regulations. Also, it is proved that the devices meet international standards of quality and functionality. What are ISO-certified devices? The devices manufactured following ISO […]
How To Make Medical Device Quality Management System?
It is difficult to run a medical business without understanding the concept of a medical device quality management system. The International Organization for Standardization has set a framework for medical device manufacturers. They provide ISO 13485 certification to educate business organizations about their framework and its advantages. Let’s discuss the salient features of ISO 13485 […]