Bruce McKean Email & Phone Number

Bruce McKean Skills

• Medical Devices
• ISO 13485
• FDA
• Validation
• ISO 14971
• Regulatory Affairs
• GMP
• Quality System
• Quality Auditing
• V&V
• 21 CFR Part 11
• Design Control
• CE marking
• CAPA
• 21 CFR
• Biomedical Engineering
• Corrective and Preventive Action (CAPA)
• Medical Device Directive
• Supplier Quality
• U.S. Food and Drug Administration (FDA)
• Cross-functional Team Leadership
• Quality Management
• U.S. Title 21 CFR Part 11 Regulation
• Verification and Validation (V&V)
• Engineering
• Sales
• Microsoft Excel
• Project Management
• Process Improvement
• Customer Service
• Corrective and Preventive Action Capa
• Cross Functional Team Leadership
• u.s. Food and Drug Administration Fda
• u.s. Food and Drug Administration
• Corrective and Preventive Action