Medical Device Description

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

Classify Your Medical Device | FDA

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

Each classified device has a 7-digit number associated with it, e.g., 21 CFR 880.2920 - Clinical Mercury Thermometer. Once you find your device in the panel's beginning list, go …

Medical devices - World Health Organization

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

Today, there are an estimated 2 million different kinds of medical devices on the world market, categorized into more than 7000 generic devices groups. A medical …

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 …

Importing Medical Devices | FDA

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

Registration and listing. Establishments that are involved in the production and distribution of …

Content of a 510(k) | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k

A description of the tests and the results obtained are essential. Reasonable and sufficient details of all test procedures and results should be submitted to FDA.

Medical Devices | Definition, categories and classification …

https://www.eurofins.com/consumer-product-testing/industries/medical-devices/what-is-a-medical-device/

Medical devices are described in article 2 of the Medical Devices Regulation (EU) 2017/745 as “instruments, apparatus, appliances, materials or other articles intended by the …

Medical Device Technical File and Its Structure - SimplerQMS

https://www.simplerqms.com/medical-device-technical-file/

A medical device technical file is a mandatory technical document that your medical devices company will submit to the concerned regulatory authorities in the EU to …

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

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

The full EU MDR Medical Device definition is: ‘medical device’means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be …

How To Write Great Medical Device Product Descriptions

https://www.caseydemchak.com/blog/how-to-write-great-medical-device-product-descriptions/

Writing a strong description of your medical device is one of the most overlooked aspects of creating an effective medical marketing campaign. Don’t make this …