Course Description

Course Description

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

Performing 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.

Requirements and Pre-Requisites

  • Basic mathematical skills
  • Medical device regulations
  • Medical device quality management system

Topics Covered in This Course

  • Overview of the ISO14971 medical device risk management process
  • Roles & responsibilities in a risk management team
  • Constructing a risk management plan
  • Applying the FMEA and 5×5 matrix in risk analysis
  • Relationship between risk evaluation, risk control and medical device testing
  • Iteration of the risk management process to evaluate residual risks
  • Using risk/benefit analysis to assess residual risks
  • Applying the Fault-Tree and Event Tree Analysis to evaluate residual risks
  • Overview of the risk management file
  • Overview of post-production information required
  • Dealing with unforeseeable risks in risk evaluation

Course Materials 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 Should Take This Course

  • Medical Device Startups
  • Members of the product development team
  • Members of the senior management team
  • Regulatory Affairs Professionals
  • Quality Assurance Professionals
  • Development Engineers
  • Operations/Production Managers
  • Technical Sales and Marketing Professionals

Medical Device Coach

Nealda Yusof

My name is Nealda. Over the past 15 years I've helped dozens of medical device businesses in Asia grow through my consulting and training programs. With background in research, regulatory, testing & validation, quality assurance, risk and crisis management, compliance and commercialisation, my passion is to develop training courses in easy-to-understand and accessible formats to increase adoption of principles & best practices, improve compliance, encourage continuous improvement and promote understanding of the medical device sector. I am constantly on a quest to find better ways to comply with regulations, be more productive and promote a knowledge-based workforce in this sector — which is exactly what I’m going to teach you.

Course curriculum