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The internationally accepted standard guideline for medical device risk management is the ISO 14971 standard.

A concise guide to executing ISO 14971 requirements
What you'll learn

Understand the ISO14971 medical device risk management requirements and sequence

Understand the roles and responsibilities of a risk management team

Construct a risk management plan

Apply the FMEA and 5x5 matrix in risk analysis

Understand the relationship between risk evaluation, risk control and medical device testing

Iterate the risk management process to evaluate residual risks

Use risk/benefit analysis to assess residual risks

Apply the Fault-Tree and Event Tree Analysis to evaluate residual risks

Understand the importance of the risk management file

Understand the type of post-production information required

Dealing with unforeseeable risks in risk evaluation

Requirements

Basic mathematical skills

Medical device regulations

Medical device quality management systems

Description

This 2.4-hour long course is based on the current ISO 14971:2007 edition. It has been designed to provide a concise but complete knowledge of medical device risk management to supplement readings of the 80-page standard and to initiate those who are new to the medical device industry. More focus has been given to explaining the use of key tools such as the Failure Mode and Effects Analysis (FMEA) and the Fault-Tree Analysis (FTA) to enable immediate application in ISO 14971 projects. This course offers a systematic methodology to comprehend medical device risk management and connects the vital elements of risk management methodologies for a more efficient application of principles. It also provides guidelines on how to conduct productive meetings to construct medical device risk profiles.

Why is this course essential to take?

Perfog risk management is a regulatory obligation and is the underpinning tool for assessing medical device safety. Risk management is part of the design input requirements during product design & development. This means that risk control and hazard reduction measures must be included as key considerations in the final medical device design, as well as in verification and validation studies. Risk evaluation should occur continuously throughout the production and post-production processes.

An organised and methodical approach to understanding and applying the ISO14971 principles

This ISO 14971 course takes a business approach to medical device risk management. Business tools such as project management techniques are recommended to establish risk management team structures. This ensures an organisation-wide support and commitment to comply with the ISO 14971 requirements. The Failure Mode and Effects Analysis (FMEA) and the Fault-Tree Analysis are discussed in greater detail to clearly explain their applicability to medical device risk management.

Course materials and resources provided

7 practice workshops

Risk management plan template

Quantitative risk/benefit analysis technical report

FMEA worksheet in MS Excel format

AAMI White Paper: Risk Principles and Medical Devices

Who this course is for:

Medical device startups

Members of the product development team

Members of the senior management team

Regulatory Affairs Professional

Regulatory Affairs Professionals

Quality Assurance Professionals

Development Eeers

Operations/Production Managers

Technical Sales and Marketing Professionals



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