The ISO 14971:2007  (Risk Assessment to Medical Devices) training course, to be delivered in Limerick as one-day public programme is designed to provide participants with an understanding of the impact that ISO 14971 has on the decision making process at medical device manufacturing firms. 

The ISO 14971:2007 training can be also delivered as a customised in-company programme at clients facilities nationwide in Ireland, including Dublin, Cork, Limerick & Galway.

Course Objectives: 

Medical products have a direct connection to patient’s health. In order to minimise the risk to the patient and ensure medical devices act in the way they are intended, it is essential that their design and manufacture be carried out to ensure they are safe and fit for use.

An essential component in the process is the assessment of the associated risks with a device and the management of these risks

Upon completion of this course, participants will have gained an understanding and knowledge of:

• The regulations pertaining to risk management
• Find out how ISO 14971:2007 fits with both the European CE Marking Regulations and FDA Regulatory requirements
• Understand the business importance of using ISO 14971:2007
• Learn how to use the standard in practice.

Pre-requirements

This course is designed for 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.

Participants Study: 

• Overview of Risk Management 
• Intro to ISO 14971
• Requirements
• FMEA, FMECA, Fault Tree Analysis
• Identifying Risks/Hazards
• Risk Assessment Techniques
• Estimating Risks
• Reduction of Risks
• Group FMEA Assignments
• Review

Course Contents:

Risk Management

• Why Risk Manage
• 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