Course description
ISO 14971:2019 Practical Application of Risk Management to Medical Devices
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 manufacturers 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.
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
Upcoming start dates
Suitability - 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.
Outcome / Qualification etc.
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 as a basis for U.S. regulatory reviews
Training Course Content
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
Course delivery details
This course includes a two-hour ISO 14971 overview module that must be completed prior to the start of the live instruction.
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
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Reviews
Average rating 5
Very informative and a lot of details were shared based on the experience of the trainer that is very useful.
There was a perfect balance of interaction. Some participants had very specific questions relating to their own company's products. The instructors were generous with their advi...
I enjoyed listening to the examples given from real situations.