Non Computerized Medical Devices

Medical devices - World Health Organization

https://www.who.int/health-topics/medical-devices

A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical …

How to Determine if Your Product is a Medical Device | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

Telehealth: Technology meets health care - Mayo Clinic

https://www.mayoclinic.org/healthy-lifestyle/consumer-health/in-depth/telehealth/art-20044878

The goals of telehealth, sometimes called e-health or m-health (mobile health), include the following: Make health care easier to get for people who live in …

Wireless Medical Devices | FDA

https://www.fda.gov/medical-devices/digital-health-center-excellence/wireless-medical-devices

Radio frequency (RF) wireless medical devices perform at least one function that utilizes wireless RF communication such as Wi-Fi, Bluetooth, and cellular/mobile phone to …

What is Digital Health? | FDA

https://www.fda.gov/medical-devices/digital-health-center-excellence/what-digital-health

Digital health technologies use computing platforms, connectivity, software, and sensors for health care and related uses. These technologies span a wide range of …

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

Device Advice. Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling …

Medical Device Regulation for non-medical products

https://www.medicaldevice-network.com/sponsored/medical-device-regulation-non-medical-products/

The devices without an intended medical purpose that fall under the Medical Device Regulation are: Contact lenses or other items intended to be introduced …

Importing Medical Devices | FDA

https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices

The following is an example of a medical device classification search for a manual toothbrush. Depending on the Class of the medical device you are importing, the …

What are Medical Devices? - News-Medical.net

https://www.news-medical.net/health/What-are-Medical-Devices.aspx

Medical devices encompass a broad range of complexity and include devices that range from highly sophisticated computerized medical equipment to two …

Devices without a medical purpose

https://bioregservices.com/blog/devices-without-a-medical-purpose/

Non-medical devices. A new category has been introduced in the Medical Device Regulation (MDR, 2017/745) – “Devices without an intended medical …