February 28, 1997
Synaptic Corporation 2/28/97 2. Failure to establish a Device Master Record which includes all device specifications including appropriate drawings, composition, formulation and component specifications. For example, the Master Record for the [purged text] does not include the checksum value of the software, which is used to assure that [purged text] are correctly programmed.
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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