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ISO 14971:2012 (Risk Assessment to Medical Device) ISO 14971:2012 (Risk Assessment to Medical Device)
This ISO 14971:2012(Risk Assessment to Medical Device) training course is a 1 Day public programme, designed to provide attendees with an understanding of the impact that ISO 14971 has on the decision making process at medical device manufacturing firms.

Dates:
Location:
Limerick

Our  ISO 14971:2012 (Risk Assessment to Medical Device) programme is also available for delivery as a Customised In-Company Course at clients’ facilities nationwide in Ireland, including Dublin, Cork, Limerick, Waterford, Galway and Sligo at very competitive rates. 

We are also available to deliver in the UK and other European countries on request.































 















For more information please contact:

Fionnuala Landers
Phone:061 514744
Email:F.Landers@optimatraining.ie

 Course Contents:

Risk Management

· Why Risk Management

· Understand the need for risk management

· Understand the regulations pertaining to risk management

Introduction to ISO 14971- Risk Management (Medical Devices):

· Structure of the standard – Medical Devices

· Requirements of the standard

· Contents and purpose of each section

· Correspondence to and differences between ISO 9001:2000

· CE marking implications

The Process:

· Risk Management Process

· Understanding the characteristics related to devices

· Identifying possible hazards

· Estimating the associated risk

· Review & reduction of risk

Risk Management/Assessment Techniques:

· Risk Management using FMEA

· Risk Management using FMECA

· Risk Management using Fault Tree Analysis

Audit Exercise using the standard:

· Attendees will break into groups and carry out an FMEA of specific areas

· Afterwards the groups will convene to share experience

· conclusions

· Responding to an Audit

Review:

· Summary & Review

This ISO 14971:2012 (Risk Assessment to Medical Device) training programme may be beneficial to Management, Product Design Managers, Engineers, Process Owners, QA and Regulatory personnel in the medical device field. It builds a strong foundation for those new to risk management standard and it provides a concise refresher to people experienced in the regulatory field.

Course Documentation

Download

For more information please contact:

Fionnuala Landers
Phone:061 514744
Email:F.Landers@optimatraining.ie

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