Risk Management for Medical Devices: ISO 14971:2007 2013

Topics

• Risk Management Process
• Risk management regulatory framework and definitions
• Risk Management Plan
• Risk Modeling
• Risk Management Assessment Training
• Risk Analysis Tools
• ISO 14971 Gap Analysis Checklist
• Risk Management Report

Who should Attend

• Design engineers, process engineers and manufacturing engineers
• Quality managers
• Personnel or vendors developing medical device software
• Internal auditors
• Medical device product managers
• Risk managers