According to DataM Intelligence, the U.S. Software as a Medical Device (SaMD) Market Size reached USD 205.12 million in 2024 and is forecast to climb to USD 715.00 million by 2033, expanding at a ...

Source, Manufacturing Process (Extrusion, CNC Machining, Injection Molding), Application (Diagnostics Equipment, Surgical ...

As a medical device startup, there are many things you are juggling and balancing all day, every day to advance your product closer and closer to that next critical milestone. And one of those things ...

The 2007 directive expands the existing definition of a medical device to cover "any instrument, apparatus, appliance, software, material, or other article, whether used alone or in combination, ...

Implantable medical devices are introduced into the human body through surgery or other medical interventions to serve specific functions. The most common examples of implantable medical devices ...

A well-written procedure documenting the complaint management process, including the creation of a complaint form, is required by the QSR. By Bob Mehta I have always experienced great difficulty in ...

A medical device is any appliance, apparatus, software, material, or other articles, which may be used in isolation or combination (as defined by the manufacturer) by individuals for a medical purpose ...

Defective medical devices — and the lack of laws or enforcement against them — have killed thousands of patients around the world and put millions more at risk. Yet, in my country and many others, few ...