Course DatesTo be verified
Risk Management of Medical Devices
COST: €795 per person including course manual, lunch and refreshments.
• Key Principles of Risk Management
• Introduction to ISO 14971:2007
• FMEA, FMECA
• Identifying Risks/Hazards
• Residual Risk – is this acceptable?
• Estimating and reduction of Risks
• Change Control and estimation of risk
• 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
WHO SHOULD ATTEND
This course is designed for Senior Management, Product Design Managers, Engineers, Manufacturing Cell Business Owners, QA and Regulatory personnel in the medical device industry.
The two day course commences at 9.15 am and finishes at 5.00 pm each day.
The successful completion of this programme by the learner does not lead to an award, but a certificate of attendance is issued to each participant.
Safety Shoes – Not Required on this course