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.
