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June 16, 2021
Company: Normand-Info S.A.S.U. Date of Enforcement Report: 6/16/2021 Class II PRODUCT Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments. Recall Number: Z-1831-2021 REASON Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of...
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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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+1-781-721-2921
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