IEC 62304 Medical Device Software - Testing Standard for Software Lifecycle Processes

Defines lifecycle requirements for medical device software. The set of processes, activities, and tasks described in this standard form a common framework for medical device software lifecycle processes. It applies to the development and maintenance of medical device software where the software itself is a medical device or where the software is an embedded or integrated part of the final medical device. This standard does not cover the verification and final version of the medical device, even if the medical device consists entirely of software.

IEC 62304 is a safety standard for medical devices and compliance with it is critical for software developers. Whether doctors, specialists or nurses, healthcare providers depend on medical devices to treat their patients. These safety-critical systems need to be safe and reliable to ensure that everything is done to prevent any catastrophic failure that could result in death or serious industry. To assess risk, the US Food and Drug Administration (FDA) has created a classification system to assist in the development of these safety-critical systems.

Medical devices can be divided into three categories:

• Low-risk devices that are not intended to support or sustain life. This may include items such as bandages, crutches, or non-powered wheelchairs;
• Medium-risk devices are in constant contact with a patient and the practitioner needs training to use them. These devices may include catheters, blood pressure cuffs, or intravenous infusion pumps;
• High-risk devices designed to sustain or support life. Class III devices are life-saving devices such as defibrillators, pacemakers, or high-frequency ventilators;

EUROLAB assists manufacturers with IEC 62304 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.