Medical Device Software is a powerful tool that helps evaluate and optimize the safety and effectiveness of medical devices, while ensuring compliance with ever-evolving regulatory requirements.
Normative Evolution: XP S99-223
(French medical device standard on benefit-risk and safety management.)
To provide a useful and easy-to-use web solution, Knowllence keeps a close eye on medical device standards.
One of these is the experimental standard XP S99-223, which was updated in December 2023. This new version makes it easier for manufacturers to measure and explain the benefit-risk ratio of their products.
Our Medical Device Software includes this updated standard, giving medical device professionals a simple and effective way to evaluate benefit versus risk.
The Benefit-Risk ratio before this update
Previously, Medical Device Software allowed users to assess the benefit-risk ratio for each identified residual risk by selecting “Yes” or “No”, along with the related justification, directly on the corresponding risk line.
Once each risk had been evaluated individually, the manufacturer could then add an overall comment on the benefit-risk assessment for the device as a whole.
The New Approach to Benefit-Risk Assessment
By participating in various working and expert sessions of the AFNOR S95B commission (French national organization for standardization.), Knowllence has contributed to developing a new way of approaching and analyzing the Benefit-Risk assessment within its software solution.
It is now possible to:
- Define the benefit evaluation criteria in alignment with the risk assessment grid
- Formalize the claims and intended benefits of the medical device
- Define the benefit-risk assessment framework
- Analyze data to estimate the expected benefits
- For each phase of the device’s lifecycle, compare the benefits with the identified residual risks
- Use this information to assess acceptability and take appropriate action
- Verify the completeness and consistency of all benefit-risk related activities
- Communicate and highlight the outcomes of the analyses performed
The software includes a dedicated table that enables users to define and evaluate the claims and associated benefits of each medical device.
These identified benefits can then be directly compared against the residual risks outlined in the analysis.
Thanks to these new capabilities, Knowllence helps medical device manufacturers easily and effectively handle the complexity and variability of their products and projects. The software allows for global benefit-risk assessment across a family of medical devices, while also taking into account the specific characteristics of each variant (i.e., individual references) — all while grouping shared elements for streamlined management.
A new summary report on the benefit-risk analysis is now available, along with various graphical indicators that are useful for monitoring and highlighting the results.