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FORMATION
ISO 14971: 2019 – Risk management of medical devices – #30
Context
You are looking to :
- to acquire a rigorous risk management approach in accordance with ISO 14971: 2019, to meet the requirements of ISO 13485: 2016 and the regulatory directives applicable to medical devices (2017/745, 98/79/EEC, 2007/47/EEC).
- Strengthen your teams’ skills in medical device risk management.
Objectives
- Know how to effectively manage risks, from product risk analysis to the monitoring of devices after distribution.
- Understand and know how to apply the risk management methodology according to ISO 14971 in your organization, and verify that suppliers are in compliance.
- Know how to document the risk management process, the risk management plan and the risk management file for a medical device.
Recommanded for
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Quality / QHSE managers, engineers and technicians.
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Regulatory affairs managers.
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People involved in the life cycle of the medical device: design, development, manufacturing, marketing, agents, importers,…
Prerequisites
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Be aware of the requirements of ISO 13485.
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Knowledge of the regulatory environment associated with medical devices.
Pedagogy
- Quizzes – practical exercises – exchanges.
Evaluation mode
- Knowledge test (MCQ).
Course materials
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Participant file containing the presentations delivered during the training and the exercise materials.
To go further
Training :
Consulting services : EURO-SYMBIOSE can assist you in the concrete implementation in your company. Contact us to know more about it.
Session 1
The context: the regulatory framework.
Session 2
General principles and field of application.
Session 3
The responsibilities.
Session 4
The risk management plan.
Session 5
The risk analysis process.
Session 6
Risk assessment and control to an acceptable level: residual risks, benefit/risk analysis, and overall residual risk assessment.
Session 7
Documentation and recording of the execution of the risk management plan and the results: the risk management file.
Session 8
Collect and review information about the medical device during the production and post-production phases to decide on possible actions.
About Instructor
Valérie LE COUËDIC
Speciality: EURO-SYMBIOSE consultant since 2001, Valérie masters both automotive and aeronautical standards. Technical contact for the VDA-QMC.