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June 11, 2019
Advanced Botanical Consulting & Testing Inc dba ABC Testing Product: Drugs Date: 6/11/19 CMS Number: 572991 The U.S. Food and Drug Administration (FDA) inspected your contract testing laboratory, Advanced Botanical Consulting and Testing Inc. dba ABC Testing (FEI 3003693795) at 1169 Warner Ave, Tustin, California, from November 1 to 13, 2018. This warning letter summarizes...
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IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.