Document App For Medical Device Manufacturers Online For Free

Mobile medical apps are medical devices that are mobile apps, that incorporate device software functionality that meet the definition of a device in section 201(h) of the Food, Drug & Cosmetic Act, and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.

Your app probably needs FDA approval if it's classified as a medical device. If the app monitors, diagnoses, cures, relieves, or prevents a condition and its symptoms, it's a medical device. In other words, if it acts like a medical device, it is one. Lots of healthcare apps aren't medical devices.

Other examples include games, social media platforms, email clients and banking apps. They can also be used to access information, such as news and weather updates, and to perform tasks, such as online shopping and booking travel.

Apps that help consumers view, use, or share their medical records or health insurance claims data or otherwise access information from their doctor, health care clinic, or health plan.

Numerous apps are now available to assist HCPs with many important tasks, such as: information and time management; health record maintenance and access; communications and consulting; reference and information gathering; patient management and monitoring; clinical decision-making; and medical education and training.

Medical Device Technical File Contents Description of the device and specification: In this section, you will include the product or trade name, along with a general description of the medical device. ... Labeling and usage instructions: This section will contain the device labels and their packaging details.

Medical Apps, also referred to as Mobile Medical Apps, are applications for mobile devices such as smartphones or tablets that support medical professionals or patients in the diagnosis, treatment or monitoring of a disease or injury.