Get the latest information on risk management concepts and practices for the medical device industry and learn how to plan your organization's risk management and analysis program. Understanding risk analysis is essential to anyone in the medical device industry-this is a focus of the design control requirements in FDA's Medical Device Quality System Regulation and ISO 14971: Application of Risk Management to Medical Devices. Risk analysis has been an essential requirement of the European Union (EU) Directives for medical devices as applied by EN 1441-Application of Risk Analysis to Medical Devices.

Learn how to manage a process associated with the identification, analysis, evaluation, and control of different types of risk in the medical device and diagnostics industries. Class discussions cover the use of failure mode and effects analysis (FMEA) and fault tree analysis (FTA) as methods of conducting risk analysis, including predictions and determining approaches to reliability and safety analysis. Also covered is the application of these tools to product design and manufacturing processes.

Objectives

• Understand the purpose, benefits and objectives of a detailed plan for risk management and analysis.
• Describe basic concepts of risk management and analysis.
• Identify risks and approaches to their solutions.
• Understand decision making on the acceptability of risk.
• Understand regulatory requirements of risk analysis.
• Use available information to analyze risk.
• Identify qualitative and quantitative characteristics of risk analysis.
• Identify hazards in risk analysis.
• Estimate and evaluate risks.
• Understand what is involved in risk reduction and control.
• Interpret risk analysis reports.
• Plan for risk management.
• Basic concepts and process model overview
• EN 1441 and ISO 14971:2007
• The 13-step process
• Meeting regulatory requirements for risk
• Four elements of risk in a management plan (ISO 14971:2007)
• Identifying risks and approaches to solutions
• Risk management file
• Acceptability of risk
• Risk analysis
• Identification of hazards and estimation of risks to public safety
• Qualitative and quantitative characteristics of risk
• Risk evaluation, control and reduction
• Overall RRE
• Risk reporting
• Postmarket information and use
• Risk review and planning
• GHTF guidance on the integration of risk in a QMS design and development process
• Corrective and preventive action process
• ISO 13485:2003 and risk management

Who Should Attend

Recommended for design managers and engineers; manufacturing, service, quality assurance, reliability, research and development, and regulatory affairs professionals, and other cross-functional team members in a medical device environment.

CEUs: 1.5
Number of Days: 2