Browse Definitions :
Definition

Software as a Medical Device (SaMD)

Software as a Medical Device (SaMD) is a regulatory compliance category for a standalone software application that is designed to complete a medical task. The SaMD category provides standards for medical apps that were designed for use on general purpose computing devices, such as smartphones or tablets. 

Practitioners can use SaMD for many purposes, including the following: 

  • Using a smart phone's accelerometer to monitor alterations of balance immediately after a stroke. 
  • Viewing an MRI or other type of medical imaging on a tablet PC.
  • Editing digital images to detect cancer.
  • Creating and documenting an action plan for treating a specific patient.
  • Monitoring body mass index (BMI) or heart rate. 

Software as Medical Device regulations

In the United States, Medical Device Class (MDC) hardware is regulated by the Food and Drug Administration (FDA). The goal of establishing an SaMD category is to allow software to conform to the same reliability, security and safety standards as dedicated MDC hardware.

The class to which a device or software app is assigned determines what type of clearance it requires before going to market. In late 2017, the FDA issued guidance for SaMD based on the International Medical Device Regulators Forum (IMDRF) document SaMD N41. The decision of whether to classify a software app as SaMD is up to the vendor.

This was last updated in August 2019

Continue Reading About Software as a Medical Device (SaMD)

SearchCompliance
  • OPSEC (operations security)

    OPSEC (operations security) is a security and risk management process and strategy that classifies information, then determines ...

  • smart contract

    A smart contract is a decentralized application that executes business logic in response to events.

  • compliance risk

    Compliance risk is an organization's potential exposure to legal penalties, financial forfeiture and material loss, resulting ...

SearchSecurity
  • email spam

    Email spam, also known as junk email, refers to unsolicited email messages, usually sent in bulk to a large list of recipients.

  • shadow password file

    A shadow password file, also known as /etc/shadow, is a system file in Linux that stores encrypted user passwords and is ...

  • browser hijacker (browser hijacking)

    A browser hijacker is a malware program that modifies web browser settings without the user's permission and redirects the user ...

SearchHealthIT
SearchDisasterRecovery
  • What is risk mitigation?

    Risk mitigation is a strategy to prepare for and lessen the effects of threats faced by a business.

  • change control

    Change control is a systematic approach to managing all changes made to a product or system.

  • disaster recovery (DR)

    Disaster recovery (DR) is an organization's ability to respond to and recover from an event that affects business operations.

SearchStorage
  • bare-metal restore

    A bare-metal restore (also referred to as bare-metal recovery or bare-metal backup) is a data recovery and restoration process ...

  • mSATA SSD (mSATA solid-state drive)

    An mSATA SSD is a solid-state drive (SSD) that conforms to the mSATA interface specification developed by the Serial ATA (SATA) ...

  • network-attached storage (NAS)

    Network-attached storage (NAS) is dedicated file storage that enables multiple users and heterogeneous client devices to retrieve...

Close