Clinical validation is the process of evaluating the clinical performance of a medical device, including its safety and effectiveness, in a real-world setting. This process is particularly important for software medical devices, which can have an impact on patient care. Before a product can be release to public use it has to be clinically validated. […]
Clinical validation for a software medical device Read More »
Working in the medical device industry, it’s important to understand the role that quality management systems (QMS) and regulations play in ensuring the safety and effectiveness of the end product. Role of Quality Management Systems (QMS) QMS is a framework of policies, procedures, and processes that a company follows to ensure that their products and
You may not have initially considered that your software product could fall under the umbrella of medical device regulation. However, it’s important to understand that any software used to diagnose, prevent, or treat a medical condition is considered a “software medical device” and is subject to specific regulations. In the coming blog posts, we’ll delve
Understanding Software Medical Device Regulation in the US and EU Read More »
