Cem Dogan Email

Cem Dogan Skills

• TS EN ISO 13485
• AS9100 Lead Auditor
• AutoCAD
• BS ISO/IEC 27001
• Business Strategy
• CMMI (Yetenek Olgunluk Model Entegrasyonu)
• Capability Maturity Model Integration (CMMI)
• Cleaning Validation
• Clinical Risk Management
• Compliance Auditing
• Continuous Improvement
• Continuous Process Improvement
• EU MDR (2017/745) & FDA 510(k)
• English
• IEC 62304 (Medical Device Software – Software Life Cycle Processes)
• IEC 62366-1
• IEC 62366-1 (Application of Usability Engineering to Medical Devices)
• ISO 13485:2016 (Quality Management Systems)
• ISO 14001
• ISO 14155 (Clinical Investigation of Medical Devices - GCP)
• ISO 14971 (Application of Risk Management to Medical Devices)
• ISO 19011
• ISO 27001
• ISO 31000
• ISO 9001
• ISO Standards
• ISO/IEC 15504 SPICE
• ISO/TS 16949
• Information Security Management System (ISMS)
• Internal Audits
• International Auditing Standards
• Kaizen
• Lean Six Sigma Black Belt
• MDSAP
• Medical Device Regulation (MDR)
• Medical Management
• Mobile Device Software
• Photoshop
• Process Quality Improvement
• Project Management
• Python (Programming Language)
• Quality Assurance Management
• Quality Control
• Quality System
• Quantitative Management
• Regulatory Affairs
• Regulatory Compliance
• Regulatory Reporting
• Research
• Risk Compliance
• Software Compliance
• Software Lifecycle Management
• Software Validation
• Sterile Processing
• Strategic Improvement
• Strategic Planning
• TS EN ISO/IEC 27001
• TS ISO/IEC 15504
• U.S. Food and Drug Administration (FDA)
• EN ISO 13485:2012
• ISO 9001:2015
• İç Denetçi
• Analysis
• Social Media
• Policy
• Data Analysis
• Microsoft Excel
• En Iso 13485
• Ts en Iso 13485