Medical Device Definition

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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 …

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

Medical device | definition of medical device by Medical …

https://medical-dictionary.thefreedictionary.com/medical+device

medical device. Any article or health care product intended for use in the diagnosis of disease or other condition or for use in the care, treatment, or prevention of disease that …

What are Medical Devices? - News-Medical.net

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

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) …

Is My Product a Medical Device? - Food and Drug …

https://www.fda.gov/media/131268/download

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

Medicinal products used in combination with a medical device. Some medicines are used in combination with a medical device, usually to enable the delivery …

Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The …

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in Software as a Medical Device (SaMD), Interoperability Science and Research CDRH research …

What is a Medical Device? (Official definition for EU, …

https://easymedicaldevice.com/medical-device-definition/

Medical Device definition from the Medical Device Regulation MDR 2017/745 The full EU MDR Medical Device definition is: ‘medical device’ means any instrument, apparatus, appliance, software, implant, …

Importing Medical Devices | FDA

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

What is a medical device? The FDA defines a medical device as: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related …

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