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Ultimate Guide To SaMD PDF PDF

42 Pages·2023·English
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by ['Durga Prasad']| 2023| 42 pages| English

About Ultimate Guide To SaMD PDF

This document provides an ultimate guide to software as a medical device (SaMD). It discusses what constitutes SaMD according to regulatory bodies like the FDA and IMDRF. Key points include that SaMD is software intended for medical purposes that performs those purposes without being part of hardware. The document outlines how to determine if a product is SaMD or software in a medical device (SiMD) and provides examples of each. It also covers global regulation and classification of SaMD as well as development, validation, cybersecurity, and postmarket requirements for SaMD.

Detailed Information

Author:['Durga Prasad']
Publication Year:2023
Pages:42
Language:English
Format:PDF
Price:FREE
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