What Are ISO Standards For Medical Devices?
Healthcare manufacturers need to follow ISO standards for medical devices. It is necessary because it is the only way to prove that the products are of international quality. The International Organization for Standardization is the only organization authorized to outline standards for healthcare manufacturers. Here are the salient features of ISO 13485 for Medical Device […]
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 […]