Leonard Glatkowski
EVP Quality Regulatory & Customer Success at Quality Means Business
Based in Columbia, United States
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Seniority
Other
Department
Other
Location
Columbia
Industry
Software Development
Company size
24
Contact information
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l•••••••@qmb.ai
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Background
About Leonard Glatkowski
Software Validation compliant to 21 CFR part 11, SAP/ERP and MDM, SME ISO 13495 2016, 14971, 21 CFR part 820,211, Design controls concepts through process and test method validation, CAPA, Supplier quality. Risk management, 510K and Technical files, MDR/MDHA, IVDMDR, and Clinical studies, Clinical evaluation reports
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