ISO 14971 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 document 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.
Who should use the ISO 14971?
The Medical Devices Regulation (MDR) (EU) 2017/745, In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 and as less as FDA’s 21 CFR Part 820 include the requirements for risk management.
ISO 14971 represents the state-of-the-art for risk management for medical devices and therefore it can be used to demonstrate conformity to the regulatory requirements.
ISO 14971 applies to risks associated with a medical device but it can also be applied to products that are not necessarily medical devices in some jurisdictions and be used by others involved in the medical device life cycle.
ISO 14971 does not apply to:
- decisions on the use of a medical device in the context of any particular clinical procedure or
- business risk management.
We can help you by:
- reviewing your documents and processes. We will be able to develop your Risk Management Process ISO 14971 aligned, tailored to your business needs.
- developing templates, such as risk management registry, or risk management plan, for your medical device technical file. In that way, you can re-use the templates, minimize your costs and make you independent on any extra consulting costs.
- creating a complete risk management file for your medical device. Based on your device’s Intended use, we will be able to assess the risk possibilities and severities of harms and to suggest risk mitigation and risk control for you.
- hosting a workshop with your team and train your team on how to conduct a risk assessment meeting
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