Applied ISO14971 Medical Device Risk Management
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 5×5 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
- Basic mathematical skills
- Medical device regulations
- Medical device quality management systems
The internationally accepted standard guideline for medical device risk management is the ISO 14971 standard. 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?
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.
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</li>
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 Engineers
- Operations/Production Managers
- Technical Sales and Marketing Professionals
A former CEO of a successful CRO startup in Singapore from 2003 to 2008, Dr. Nealda Yusof’s experience in the medical technology sector spans 16 years. Specialising mainly in medical devices, she has been actively involved in the entire product lifecycle process ranging from research, regulatory, testing & validation, quality assurance, risk and crisis management, compliance and commercialisation. She advised multinational heavyweights in the healthcare sector such as GlaxoSmithKline and Edwards Lifesciences, and worked in close collaboration with NAMSA and Charles River. In 2012, she was appointed to an advisory role to the CEO in a renal care group and tasked to oversee teams in the United Kingdom, Germany, Egypt and Turkey. Her work involves setting guidelines for successful business operations, product development, R&D, subsidiary communications, project management, ERP system and organisational development strategies. Dr. Yusof uses her background in both science and law to provide a holistic combination of technical, regulatory and liability perspectives.
Dr. Nealda Yusof obtained her Doctor of Philosophy (Ph.D.) in Material Science from the National University of Singapore, and a Bachelor of Law (LLB) with Honours from the University of Birmingham in the United Kingdom.