Risk Management of Medical Devices

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


COST 
€795 per person. This cost is inclusive of course manual, lunch and refreshments.

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: 
First Polymer Training,
7 Centre Court, Blyry Business and Commercial Park,
Athlone
Co. Westmeath

DURATION:
The two day course commences at 9.15 am and finishes at 5.00 pm each day.


CONVENIENT HOTELS (w/parking)

Creggan Court Hotel, Athlone
Tel: 090-6477777 (2 mins by car)

Radisson SAS,
Northgate Street, Athlone.
(Book through us for a special rate)