Course Content:
- Introduction & Course Objectives
- Risk Management
- Why Risk Management
- Understand the need for risk management
- Understand the regulations pertaining to risk management
- Introduction to ISO 14971– Risk Management (Medical Devices):
- Structure of the standard – Medical Devices
- Requirements of the standard
- Contents and purpose of each section
- Correspondence to and differences between ISO 9001:2000
- CE marking implications
- The Process:
- Risk Management Process
- Understanding the characteristics related to devices
- Identifying possible hazards
- Estimating the associated risk
- Review & reduction of risk
- Risk Management / Assessment Techniques:
- Risk Management using FMEA
- Risk Management using FMECA
- Risk Management using Fault Tree Analysis
- Audit Exercise using the standard:
- Attendees will break into groups and carry out an FMEA of specific areas
- Afterwards the groups will convene to share experience
- Conclusions
- Responding to an Audit
- Q&A
- Conclude & Follow Up Process
