Crafting an intended purpose in the context of Software as a Medical Device (SaMD)

Name: Crafting an intended purpose in the context of Software as a Medical Device (SaMD)
Creator: Medicines and Healthcare products Regulatory Agency
License: https://www.nationalarchives.gov.uk/doc/open-government-licence/version/2/
Keywords: guidances,intended-purpose,manufacturers,medical-devices,obligations,samd,software,software-as-a-medical-device

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Health And Social Care

Published

March 22, 2023

Last updated

March 22, 2023

Description

Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.

Organization

Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧

Country / Region

United Kingdom

License

Open Government Licence 2.0 (United Kingdom)

Feedback

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1 Main file

Crafting an intended purpose in the context of software as a medical device (SaMD)

Updated on March 22, 2023

html

URL: https://www.gov.uk/government/publications/crafting-an-intended-purpose-in-the-context-of-software-as-a-medical-device-samd/crafting-an-intended-purpose-in-the-context-of-software-as-a-medical-device-samd
Permalink: https://data.openrid.co/en/datasets/r/16d9bc26-9abe-4b99-8b55-ccec75522b40
MIME Type: text/html

Created on: March 22, 2023
Modified on: March 22, 2023