FMEA and Risk Management for Medical Devices 2012

Topics

• Risk Management vs.ISO 13485:2003
• FMEA & FMECA
• FDA`s Risk Management Requirements
• Risk Management & ISO 14971
• Medical Device Directives & Risk Management
• Design Control Risk Management

Who should Attend

Quality System Auditors, Quality & Regulatory Professionals, Marketing Product Managers and Manufacturing & Design Engineers.