Why Should You Attend:Medical Device Companies are using different tools to identify and manage the risks but sometimes companies lack the over all process to connect the dots. This gap has resulted in several field failures and significant recalls of the products due to inappropriate prioritization of risks involved. ISO 14971 provides a comprehensive model to not only identify the risk, but also to prioritize and mitigate the risks to as low as reasonably possible. The scope includes the entire product realization process including the afterlife disposal of the devices.
This 3.5 hr webinar will discuss the key elements of the risk management process, FDA recognized risk management model and how to connect different activities to better understand the product and process risk and risk mitigation.
Learning Objectives: - FDA recognized Risk Management Model
- Detect risks early in the Design & Development phase
- Improve product performance by mitigating risks
- Helps differentiate your product from the competition
- Helps the team and management talk the same language
- Effective way to prioritize the risks
Areas Covered in the Seminar: - Risk Management Plan
- Risk Analysis (Intended Use, Identification of Hazards, Estimation of Risks).
- Risk Evaluation.
- Risk Control (Risk Control Option Analysis, Implementation of Risk Control Measure(s), Risk/benefits analysis)
- Evaluation of overall residual risk acceptability
- Risk Management Report
- Production & post-production information
Who Will Benefit: - R&D Engineers / Managers
- Quality Assurance Personnel
- Regulatory Affairs Personnel
- Advanced Manufacturing Personnel
- Manufacturing /Operations Personnel
- Consultants
Note: Use this promocode(
117660) for 10% discount.
