September 1, 2021
Company: Beckman Coulter Inc. Date of Enforcement Report: 9/1/2021 Class II PRODUCT Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments. Recall Number: Z-2332-2021 REASON There is a potential that the data management system may add additional cells to...
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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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