This marcus evans conference presents a unique and holistic approach to effectively managing risk. Case study presentations will tackle how to adopt an integrated and proactive approach to risk management and product safety. Attendees will develop a strategy to incorporate risk management throughout all phases of the product lifecycle.

We will address the proactive trends facing risk management and quality assurance as fundamental parts of each stage of development. Additionally, we will extend the understanding of exigent International Organization for Standardization (ISO) standards to better equip medical device professionals for integrating risk management throughout quality, regulatory, and compliance areas and developing a robust risk plan.

By bringing together leading professionals in Quality, Regulatory Affairs, and Compliance; participants will have the opportunity to benchmark current risk management strategies against other peer organizations as well as interpret new FDA guidance.

Key Topics

• Develop a robust and integrated risk management plan to improve quality management and product success
• Revitalize risk reporting to enhance management and mitigation effects
• Anticipate and React to changes and updates in risk management requirements to ensure compliance
• Establish the vitality of risk management to improve functionality
• Synthesize risk management efforts with those of regulatory and notified bodies to streamline compliance efforts