Contact Details
Phone: 00 353 (0)90 6471223       Email: info@firstpolymer.com

Risk Management of Medical Devices

Course Dates

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Risk Management of Medical Devices

COST: €795 per person (10% discount for Plastic Ireland/Ibec members) including course manual, lunch and refreshments.

COURSE DETAILS:

• 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.

VENUE:
7  Centre  Court, Blyry Business and Commercial Park, Athlone.

DURATION:
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

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