Risk Management of Medical Devices

• Key Principles of Risk Management
• Introduction to ISO 14971:2019
• FMEA, FMECA
• Identifying Risks/Hazards
• Residual Risk - is this acceptable?
• Estimating and reduction of Risks
• Group FMEA Assignments
• Product Life Cycle Management
• Product Design Phase
• Product Production Phase
• Post Production Review- Customer feedback, Substitutes evaluation, Competitor evaluation and Clinical Review
• Product Risk Management Self Certification and Technical files
• Technical File Management of Risk

Programme overview

This risk Management training course is a 2 Day  programme, designed to introduce the trainee to the risk management processes & tools required to effectively manage risk.

Who is the course for

This course is designed for Senior Management, Product Design Managers, Process Engineers, Manufacturing Cell Business Owners, Production Team Leaders QA and Regulatory personnel working on risk in industry.

Learning outcomes

Learners will have an complete understanding of:

The Risk Management  Lifecycle

Risk Documentation

Risk Management Standards