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Medical Devices

Medical Device regulation is both voluminous and complex as well. Requirements to embedded software vary significantly between the regions.

21 CFR 820 analysis

In the continuity of the Annex 11 cross walk, Orlando López released in September 2011 a detailed analysis of 21 CFR 820. Additionally this document contents an update of various references based on the current regulatory context and standard.

Orlando Lopez - computer-systems-validation.com - is a well recognized expert within the pharmaceutical industry and an active member of the GAMP® Community.

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Last update: 2017-01-01

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