About ISO ISO 14971:2019
Specifies terminology, principles and a process for Risk Management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this Standard intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this Standard are applicable to all phases of the life cycle of a medical device. The process described applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability
Training Shall Broadly Cover
- Define risk management terminology
- Explain how risk management relates to the product lifecycle
- Outline the stages of the risk management process
- Exercises/Workshops with real-life scenarios and case studies to make the training session interactive and more engaging.
- Define the key deliverables of the risk management process
- Apply risk management principles within your organization
- Identify the links between ISO 14971:2019 and ISO 13485:2016.
- Dedicated ‘Question and Answer’ sessions to facilitate and provide participants with the opportunity to engage actively, seek clarification, and deepen their understanding through interactive dialogue.
Prerequisites
There are no formal prerequisites for attending the training ‘ISO 14971:2019-Medical Devices-Application to Risk Management to Medical Devices. However, it is preferred if the participant has a basic understanding of concepts of Risk Management and Medical Devices.
Who Should Attend?
- Quality Assurance/Quality Control Professionals
- Internal Auditors
- Process Owners and Managers
- Regulatory Affairs Personnel
- Training Coordinators
- Management Representatives
- Assessors, etc.
What’s Included
- Learning materials
- Copy of ISO 14971 (For Training Purpose only)
- Certificate of Participation (Certificate shall be issued as a ‘Soft Copy’ from our Training Portal. This certificate can be verified anytime from our website tcb.qcin.org by entering its unique ID number or scanning the QR Code)
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