Risk Management for Medical Devices: ISO 14971:2007

Why Should You Attend:

Medical device companies are required to implement a risk management program as an integral part of their product development activities. Risk management assessment is utilized to manage hazards and potential hazards throughout the product lifecycle, and is required for regulatory compliance. Known hazards must be eliminated or mitigated to achieve the highest possible level of safety and effectiveness of the product for its intended use. Once a product is marketed, the company is also expected to maintain the risk management program, monitoring for new potential hazards and taking preventive action to lower the probability of harm to stakeholders.

Learning Objectives:

• Promoting product safety and effectiveness
• Making better project management decisions during product development
• Complying with current standards and regulations
• Overview of basic risk modeling tools
• Promoting quality and customer confidence

Areas Covered in the Webinar:

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