Risk Management Training

Risk Management has become the international de facto means for demonstrating device safety by the US FDA, the EU, the Medical Device - Single Audit Program (MD-SAP) and every regulatory agency that employs IEC 60601 and ISO 13485 as the basis of their product safety regulatory process.  This class provides students with a comprehensive understanding of the ISO 14971 Risk Management standard as well as practical examples of implementing the standard to define and control the hazards of your medical device.  The class includes guidance on how to write your Risk Management process and how to implement it.  Covering three full days of instruction, this class includes the following topics:

• Introduction and Concepts of Risk Management
• How Risk Management is Integrated into Compliance Requirements
• ISO 14971 - It's Beginning and Where it is Today
• General Requirements for Risk Management
• The Risk Management Plan
• Risk Analysis
• Risk Evaluation
• Risk Control and Reduction
• The Risk Management File
• Risk/Benefit Analysis
• The Risk Management Report
• Production and Post-production Activities
• Risk Management in the Regulatory Process and Your Quality System