№ lp_1_2_55864
Provides a structured framework for classifying and assessing software intended for medical purposes without being part of a hardware device, including considerations for risk, lifecycle, and regulatory context.
Year: 2014
Organization: International Medical Device Regulators Forum (IMDRF)
Author: IMDRF Software as a Medical Device (SaMD) Working Group
Document Type: Guidance / Framework
Target Audience: Manufacturers, Regulators, Users
Scope: Software intended for medical purposes independent of hardware devices
Date Published: 18 September 2014
Copyright: © 2014 by the International Medical Device Regulators Forum
Price: 8 / 10 USD
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