Medical Device Software Classification

Global Approach to Software as a Medical Device | FDA

https://www.fda.gov/medical-devices/software-medical-device-samd/global-approach-software-medical-device

The International Medical Device Regulators Forum (IMDRF) Software as a Medical Device Working Group (WG) published a possible risk categorization framework for Software as a Medical Device.

Software as a Medical Device (SaMD) | FDA

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

Software as Medical Device: Classification and Definitions

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

Software as Medical Device: Definitions and Classification Aids With software as medical device, it differentiates between standalone software and software that is part of a medical device. Classifying the …

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 (typically mobile apps) that transform a mobile platform into a regulated medical device and therefore are the focus of the FDA's regulatory …

Classify Your Medical Device | FDA

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

Each classification panel in the CFR begins with a list of devices classified in that panel. Each classified device has a 7-digit number associated with it, e.g., 21 CFR 880.2920 - …

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 …

Different classifications rules for medical device software

https://medicaldevicehq.com/articles/introduction-to-different-classifications-rules-for-medical-device-software/

Introduction to different classifications rules for medical device software The four concepts in the medical device software classification. It might be confusing, in the beginning, to be... Medical …

IEC 62304 standard and software safety classifications

https://medicaldevicehq.com/articles/an-overview-of-the-iec-62304-standard-and-software-safety-classifications/

As you can see, the software safety classification is divided into A, B and C, where A is the lowest class, which means the software is not likely to contribute to …

Safety Classes versus Level of Concern - Johner Institute

https://www.johner-institute.com/articles/software-iec-62304/safety-classes-level-of-concern/

Both, European and US regulations, distinguish three different categories of medical device software, the software safety classes accordingly to IEC 62304 respectively the FDA …

Medical Device Classification (FDA & EU MDR)

https://www.simplerqms.com/medical-device-classification/

The US FDA’s classification of a medical device is based on its risk. Low and moderate-risk devices are classified as either Class I or Class II medical devices. …