Location

Productivity and Quality Institute - Alexandria

Objectives

• this course learns you the common risk-management methods used in product design and manufacturing processes. It also focuses on recently enacted standards specifically related to medical device risk management. Using case studies and interaction

Outcomes

you will practice identifying and analyzing potential product and process hazards, FMEA, hazard and Fault Tree Analysis, Hazard and Critical Control Point, and all the critical skills needed to create a risk management plan, process, report and file.

Course Contents

• General Overview of Risk Management• The Clauses of ISO 14971 and how they relate to your specific devices• Management responsibilities• Failure Mode and Effects Analysiso Designo Process• Risk Mitigation Approacheso Benefit/Risk Analyseso Residual Risk Analysis• Post-Market Surveillanceo Post-Market Clinical Follow Upo CAPAs and NCRs