Risk Management for Medical Devices ISO 14971 2007
Description: The company is required to implement a risk management program as an integral part of its quality system. A robust risk management program identifies and manages hazards throughout the product lifecycle. Once identified, hazards must be eliminated or mitigated to achieve the highest possible level of product safety and effectiveness. The company depends on its risk management program to continuously monitor and evaluate potential hazards associated with its products, and to take appropriate actions designed to lower the probability of harm to stakeholders. Key Points Covered: Regulatory Framework Definitions Risk Management Process Risk Modeling Risk Management Plan Risk Analysis Tools Risk Management Training Requirements Risk Management Report Objectives of the Presentation: Understand how to manage risk to promote product safety and effectiveness Comply with current standards and regulations Make better project management decisions Provide exposure to basic risk modeling tools Promote customer confidence Who can Benefit: Quality Managers Regulatory Managers Program Managers Project Managers Product Development Managers R & D Managers
Training Options Duration: 60 Minutes Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.