Software Accessory Medical Device

Medical Device Accessories | FDA

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

The accessory classification pathways apply to software used for medical purposes, including software that meets the definition of Software as a Medical Device (SaMD) provided by the...

Software as a Medical Device (SaMD) | FDA

https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd

What are examples of Software as a Medical Device? | FDA

https://www.fda.gov/medical-devices/software-medical-device-samd/what-are-examples-software-medical-device

Software as a Medical Device may be interfaced with other medical devices, including hardware medical devices, and other software as a medical device software, as well …

Software as Medical Device: Classification …

https://www.johner-institute.com/articles/software-iec-62304/software-as-medical-device/

Software that is part of a medical device (often referred to as embedded software) (standalone) software that is an accessory for a medical product such as for forwarding …

Examples of Device Software Functions the FDA Regulates

https://www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-device-software-functions-fda-regulates

Software functions that are used in active patient monitoring or to analyze patient-specific medical device data and therefore are the focus of the FDA's regulatory …

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

Step 1: Determine if your product meets the definition of a medical device per Section 201 (h) of the Food, Drug & Cosmetic Act. Step 2: Determine if an …

Software as a Medical Device - Demystifying EU MDR

https://www.med-technews.com/medtech-insights/medtech-regulatory-insights/software-as-a-medical-device-demystifying-eu-mdr/

Software that directly controls a medical device (hardware); provides immediate decision-triggering information (e.g. blood glucose meter software); provides …

Accessories for Medical Devices - Johner Institute

https://www.johner-institute.com/articles/regulatory-affairs/and-more/accessories-for-medical-devices/

“Accessories for medical devices are articles, substances and preparations made from substances which do not in themselves constitute medical devices according to …

Regulatory Challenges with Software as a Medical …

https://www.celegence.com/regulatory-challenges-software-medical-device-mdsw-eu-mdr/

The term Software as a medical device is defined by the MDCG as a set of instructions that processes input data (data provided through the use of a human data-input device) …

Medical Device Accessory MDR | I3CGLOBAL

https://www.i3cglobal.com/accessories-of-medical-devices/

As per the MDR, the definition of the medical device accessory is the article which is intended to be used together with one or several medical devices to enable …