ISO 14971:2019 - Risk Management for Medical Devices and IVDs - Practical Application
About This Course
ISO 14971 provides guidelines for manufacturers to establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks of these hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is an integral part of a manufacturer’s QMS.
This course presents the key foundations of the risk management process defined in ISO 14971 and provides expert tips on how to navigate the process.
This instructor-led two-day medical device risk management training is highly interactive and includes practical instruction, case study exercises and a competency assessment. This course also includes a self-paced two-hour ISO 14971 overview eLearning module that must be completed prior to the start of the live instruction.
At the end of the course, you will understand how to:
- Evaluate the fundamental requirements of the medical device regulation relating to risk management
- Apply the ISO 14971 step-wise approach of risk identification, assessment, control and evaluation
- Know how to implement risk management within the product development, product manufacturing and postmarket phases of a product lifecycle
- Establish risk acceptability criteria
- Use risk management tools and activities for defining product characteristics to prepare risk management summaries for regulatory submission
- Understand the tools, techniques, information and records required to develop a successful risk management program and use it as a basis for U.S. regulatory reviews
Key Learning Objectives
On completion of this medical device risk management training, delegates will be able to:
- Identify the structure and key concepts of ISO 14971 including production and post-production risk management requirements
- Understand the process of CAPA activities and postmarket surveillance
- Understand each step of the risk management process, including risk management planning, risk analysis, risk evaluation, risk management review and reporting, etc.
- Create an effective risk management plan
- Identify regulatory requirements for risk management
- European Regulation EU 2017/745 (EU MDR)
- European Regulation EU 2017/746 (EU IVDR)
- 21 CFR Part 820.30(g)
- Identify requirements of key international standards relative to risk management:
- ISO 14971:2019
- ISO 13485:2016
- Recognize risk management definitions and principles
- Identify how risk management affects quality management system practices
- Recognize one method for the practical application of risk management principles
Who Should Attend
This course is vital for any medical device professional looking to expand their knowledge of comprehensive risk management processes and their interactions with the design and development activities of an organization.
Course tutors can include:
Robert Ruff - Rob has over 30 years’ experience in the medical device and public health sectors, including completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). He also developed FDA’s computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.
James Pink - James Pink has over 20 years of experience in the medical devices industry including 10 years as a health care technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assurance programs for active and non-active implantable and combination products. Mr. Pink is a contributor to several medical device standards committees including ISO 13485, ISO 14971 and various product-related standards.