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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
- Is your product a Device Software Function?The FDA refers to software functions that are device functions as “device softw…What to do if your product is not a medical deviceIf your product does not meet the definition of a medical device, it may … See more
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 …
What are Medical Devices? - News-Medical.net
- https://www.news-medical.net/health/What-are-Medical-Devices.aspx
- The broad definition of medical devices. A medical device is considered any apparatus that does not exert its action through chemical means and is used in …
MDR - Article 2 - Definitions - Medical Device Regulation
- https://www.medical-device-regulation.eu/2019/07/10/mdr-article-2-definitions/
- For the purposes of this Regulation, the following definitions apply: (1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, …
Medical device | definition of medical device by Medical …
- https://medical-dictionary.thefreedictionary.com/medical+device
- medical device: FDA Any article or healthcare product intended for use in the diagnosis of disease or other condition, or for use in the care, treatment or prevention of disease, …
Factsheet: medical devices overview
- https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/factsheet-medical-devices-overview
- A medical device is any apparatus, appliance, software, material or other article, whether used alone or in combination, intended by the manufacturer to be used by …
Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- A medical device may contain an ancillary medicinal substance to support the proper functioning of the device. These products fall under the medical devices …
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 is a Medical Device? (Official …
- https://easymedicaldevice.com/medical-device-definition/
- ‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one …
Medical devices: information for users and patients
- https://www.gov.uk/guidance/medical-devices-information-for-users-and-patients
- A medical device is a healthcare product or piece of equipment that a person uses for a medical purpose. It is not a medicine or drug. Medical devices can …
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