Medical Device Quality Systems, CAPA and European Medical Device regulations 2012

Topics

• ISO 9001 & ISO 13485 Differences
• Principles of ISO 13485:2003
• FDA’s MDR’s & EU Vigilance
• Risk Management & ISO 14971
• Requirements
• Design Control
• CAPA & Risk Management
• Correction vs. Correction Action
• Corrective Action Effectiveness
• Determining Root Cause
• Linking CAPA to other parts of the quality system including customer complaints, customer feedback, supplier performance, and manufacturing non-conformities
• Quality System Trending
• MDD 93/42/EEC & Essential Requirements

Who should Attend

Attendees from medical device companies, including Quality System Auditors, Quality & Regulatory Professionals, Marketing Product Managers and Manufacturing & Design Engineers.