Useful US guidance on device software.
نویسنده
چکیده
The use of software in medical devices and their accessories has led to significant improvements in clinical diagnosis and treatment of a vast range of illnesses. However, to benefit patients and users, device-related software must be properly developed and tested before use. This article discusses a United States guidance document that describes the type of documentation needed to show that this has been done.
منابع مشابه
The Effects of Ultrasound-Guided Dry Needling on Patients With Myofascial Pain Syndrome: A Review Study
Objectives: Dry Needling (DN) is a novel and effective intervention for patients with Myofascial Pain Syndrome (MPS). Some characteristics, such as needle penetration depth, needle insertion into the target muscle, and trigger points must be identified in this intervention. The Ultrasound (US)-guided DN is a technique that involves needle insertion at the site of injury and the simulation of ti...
متن کاملUltrasound Imaging in Radiation Therapy: From Interfractional to Intrafractional Guidance
External beam radiation therapy (EBRT) is included in the treatment regimen of the majority of cancer patients. With the proliferation of hypofractionated radiotherapy treatment regimens, such as stereotactic body radiation therapy (SBRT), interfractional and intrafractional imaging technologies are becoming increasingly critical to ensure safe and effective treatment delivery. Ultrasound (US)-...
متن کاملSafety Critical Software Process Assessment: How MDevSPICE® Addresses the Challenge of Integrating Compliance and Capability
One of the primary outcomes of a software process assessment is visibility of the capability of a software process which among other things, informs us of the ability of a process to deliver consistent product quality levels. In safety critical domains, such as the medical device sector, high product quality – and particularly high product safety is an important consideration. To address this s...
متن کاملFDA draft guidance on computerised systems used in clinical trials.
When using computer systems to manage clinical studies, it is important to understand how these systems should be controlled and, for studies intended to support United States (US) regulatory submissions, when and how US regulations on electronic records and signatures apply. This article discusses these issues and a draft guidance document.
متن کاملExamining the Effects of Lighting Effects on Peripheral Devices for Visual User Notifications
The ubiquitous and pervasive use of lighting effects embedded into peripheral hardware has gained popularity through it’s use in Triple-A video game titles such as Call of Duty and the availability of software development kits (SDK) from leading manufacturers. A preliminary NASA TLX experiment was performed to examine the effect that notifications displayed on a peripheral device has, in compar...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- Medical device technology
دوره 16 10 شماره
صفحات -
تاریخ انتشار 2005