ISO 14971:2019

Medical Device Suite helps you analyse your risks under ISO 14971: Medical Devices — Application of Risk Management to Medical Devices. This standard has been revised, and the newer version, ISO 14971:2019, was published in December 2019.

The standard now provides additional information on the terminology linked to applying risk management to medical devices. It also expands on risks/benefits and post-market surveillance.

ISO 14971:2019? Knowllence’s Tool

Our Medical Device Suite programs allow you to integrate the elements found in the standard easily into your processes.
In addition to applying the changes to the standard, Medical Device Suite has also updated the following:

  • The software interface is more user-friendly, with easy access to the menus.
  • Management of combined risks and risks resulting from measures is more intuitive.
  • It’s easier to consider and evaluate a new risk stemming from a measure or a combination of risks.
  • We’ve refined the factoring of variants by the medical device family,  and you can manage your risks by family while retaining the particularities of each reference more precisely.
  • The monitoring of reviews linked to risk analyses has been integrated and can be exported.
  • The tool has new operating reports for your risk analyses that include reports cross-referenced between devices.
  • New reports let you build your risk management plan in coherence with your risk analysis.
  • We’ve added a link to the Process FMEAs and the control plan for customers using the FMEA module.
  • You can now evaluate risks related to software components in compliance with ISO 62366 (specific evaluation grid without frequency and with detection).
  • We’ve reinforced password management and made input more secure.

This new version will be available through maintenance contracts for our customers in the same ways as the usual validation file.

Who needs to pay attention to ISO 14971:2019?

The new standard version “specifies the 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.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.”

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