In this Medical device training understand the expectations of FDA and the EU in applying risk analysis to medical devices. Risk Management is required by ISO 13485 and risk analysis by the FDA’s Quality System Regulations (QSR) and by of the EU medical device regulations. Using practical examples, this course look at the regulatory and reporting requirements of EN ISO 14971, 'Medical devices - application of risk management to medical devices'.
The FMEA tool is used to provide an understanding of risk management and risk analysis techniques and methodologies, and to develop the skills required to apply these methodologies appropriate to a particular product. Risk management and analysis is considered throughout the entire life-cycle of the product, in design, production and distribution processes. The use of FMEA (Failure Mode and Effects Analysis) in identifying hazards, their severity, the probability that they might occur and the probability of preventing/detecting the hazard. are considered. Control measures and the monitoring of the effectiveness of such controls are discussed.
The FMEA tool is used to provide an understanding of risk management and risk analysis techniques and methodologies, and to develop the skills required to apply these methodologies appropriate to a particular product. Risk management and analysis is considered throughout the entire life-cycle of the product, in design, production and distribution processes. The use of FMEA (Failure Mode and Effects Analysis) in identifying hazards, their severity, the probability that they might occur and the probability of preventing/detecting the hazard. are considered. Control measures and the monitoring of the effectiveness of such controls are discussed.
Areas Covered in the seminar:
- Understand the expectations of FDA and the EU in applying risk analysis to medical devices
- Understand the application of the risk analysis standard ISO 14971 to medical devices
- Understand the application of risk analysis methodologies such as FMEA and FTA to medical devices
- Understand the principles of risk management planning in developing procedures and practices to analyze, evaluate and control risks
- Learn how to use a product safety audit to identify potential areas of risk exposure and liability exposure
Who Will Benefit:
- R&D Managers/Engineers
- Members of Design Review Teams
- RA/QA Managers/Engineers
- Sales and Marketing Management
- Management Representatives
- Product, Project, and Program Managers
- Internal Auditors
- Members of multi-discipline Design Teams
Course Provider
Angelo Scangas,
