Day

March 5, 1997
Internazionale Medico Scientifica 3/5/97 Mammography Systems The above-stated inspection revealed that these devices are adulterated under section 501(h) of the Act, in that the methods used in, and the facilities or controls used for the manufacturing, packing, storage, and installation are not in conformance with the Good Manufacturing Practice (GMP) for Medical Devices Regulations, as...
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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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