DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/fm5tv6/medical_device) has announced the addition of the "Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency: 2-day In-person Seminar (September)" conference to their offering.
FDA views risk management as an essential process both during inspections and in the review of pre-market submissions. Effective risk management has become critical to medical device manufacturers and this interactive two day seminar is aimed at providing medical device professionals with the tools necessary for effective risk management implementation in device manufacturing and marketing.
It will address both the fundamentals of risk management as well as current best practices for ISO 14971 compliance. The course will look in detail at risk management requirements in the US, the EU, and other parts of the world. Taught using an interactive workshop format, attendees will practice all the risk management activities required by ISO 14971. Exercises are aimed at demonstrating efficient and effective use of risk management, including best practices in applying the ISO standard. Emphasis is placed on practical solutions to practical problems.
Key Topics Covered:
Day One (8:30 AM - 4:30 PM)
Registration Process: 8:30 AM - 9:00 AM
Session Start Time: 9:00 AM
1. Introduction
2. Risk management essentials and requirements
3. Establishing a risk management policy
4. Risk management planning
5. Risk acceptability criteria/constructing a risk chart
6. Preliminary analysis
7. Risk Analysis tools
8. Estimating risk
9. Using standards and risk management
10. Risk Evaluation and Risk Control
Day Two (8:30 AM - 4:30 PM)
11. Risk Control (continued)
12. Risk/benefit analysis
13. Overall residual risk & the risk management report
14. Assessing production & post-production information
15. Wrap up
For more information visit http://www.researchandmarkets.com/research/fm5tv6/medical_device
