Uncategorized
Want to learn how to get your medical devices to market faster and with fewer risks? In this article we cover 6 software solutions by RegDesk that address the most common challenges faced by regulatory affairs teams and reveal how most companies are making the medical...
Asia
The present article describes in detail a new resolution issued in Jordan, by the virtue of which the authority describes the medical device license renewal procedure. Table of Contents Jordan has adopted a new circular resolution establishing the...
China
Under the general rule, combination products constitute a specific group of products consisting of both medicine (drug) and medical device. In such a case, both products (medicine drug and medical device) are supplied together and intended to be used together for a...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the principles of software validation. The scope of the document covers, inter alia, the aspects...
FDA
The present article details FDA guidance on software testing, including tests performed by the manufacturer (software developer) regarding potential changes to the software. The basics of software testing are described in the initial article. The Food and Drug...
#WednesdayWebinar Join us for our upcoming webinar Global Regulatory Changes to Expect in 2025 January 22, 2025 at 10 AM ET
Register Now
