ISO 14971:2019 - Risk Management for Medical Devices and IVDs - Practical Application
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About This Course
ISO 14971:2019 provides guidelines for manufacturers to establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks associated with the identified 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 quality management system.
This instructor-led two-day course presents the key foundations of the risk management process defined in ISO 14971:2019 and provides expert tips on how to navigate the process.
This course is highly interactive and includes practical instruction, case study exercises and a competency assessment.
This course also includes a self-paced two-hour ISO 14971:2019 overview eLearning module that must be completed prior to the start of the live instruction.
Key Learning Objectives
At the end of this training, learners will be able to:
- Identify regulatory requirements for risk management:
- European Regulation EU 2017/745 (EU MDR)
- European Regulation EU 2017/746 (EU IVDR)
- 21 CFR 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 entire lifecycle of a medical device from conception to decommissioning and disposal.
Course tutors selected from the following:
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.
Ashley Kelleher - Ashley has more than 14 years of professional experience in the medical device, pharmaceutical and certification industries. Her experience includes program management and project management of global, third-party, and notified body certifications for the medical industry. In addition, Ashley has expertise in reviewing technical file documentation (CE marking) and holds lead auditor certifications for ISO 13485, GDP, MDSAP, EU-MDR, ISO 14971, ISO 9001, and ISO 15378. Her educational background is in veterinary science.