Software-related medical devices are taking over the medical device industry. There are three types of software-related medical devices in the industry software as medical devices, the software is integral to medical devices, and software used in the manufacturer or maintenance of a medical device1. Software that is integral to a medical device is software that is within the medical device itself though this piece will focus on Software as a Medical Device.

Software as a Medical device is defined as, software intended to be used for one or more medical purposes that perform its purposes without being a part of the medical device hardware1. Software as a Medical Device is also known as health software, standalone software, and medical device software. Software as a medical device empowers stakeholders and regulators to encourage safe innovations and protect patient safety.

Software as a medical device covers a broad range of devices such as:

  • Software with a medical purpose that operates on a computing platform
  • Software that is connected to a hardware medical device
  • Software that is interfaced with other medical devices
  • Software that is capable of running on general/nonmedical computing platforms2

Software as a Medical Device includes software that allows images to be obtained from a medical device and Computer-Aided Detection software that perform image processing. However, if the software is a part of the hardware of the medical device it does not fall into the category of Software as a Medical device this includes but is not limited to software for clinical communications, software that monitors device performance, and software utilized to pump medications2.

The International Medical Device Regulators Forum (IMDRF) formed the Software as a Medical Device Working Group to develop guidance to support the access to safe, innovative, and effective Software as a Medical Device across the globe1. The IMDRF works closely with the Food and Drug Administration (FDA) to understand the risks and categorization of Software as a Medical Device. If your company needs assistance with Software as a Medical Device or medical devices overall, EMMA International is here to help. For expertise on medical devices, contact us by phone at 248-987-4497 or by email at info@emmainternational.com.

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[1]Food and Drug Administration (December 2018) Software as a Medical Device, Retrieved on May 31, 2022, from https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd

2Food and Drug Administration (December 2017) What are examples of Software as a Medical Device, Retrieved on May 31, 2022, from https://www.fda.gov/medical-devices/software-medical-device-samd/what-are-examples-software-medical-device

Sarah Koehler

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.

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