Thomas Schultze
Principal Consultant at Toscano Consulting Group
Based in San Diego, United States
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Seniority
Director
Department
General Business & Management
Location
San Diego
Industry
Business Consulting and Services
Company size
9
Contact information
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t•••••••@thetcg.org
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Background
About Thomas Schultze
CISSP-certified technology leader with 20 years in pharmaceutical, biotech, and medical-device software. My focus is secure system architecture, data-integrity governance, and practical AI/ML applications that meet regulatory requirements and industry standards.Core strengths:• Security & Data Integrity: Design and audit controls aligned with ISO 27001, NIST, and 21 CFR Part 11• AI/ML Enablement: Integrate ML and advanced analytics to improve quality oversight and decision-making• Regulatory Expertise: Lead CSV/CSA activities under Annex 11, ISO 13485, and IEC 62304• Global Collaboration: Guide cross-functional teams across North America, Europe, and APAC
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