How can benefits and risks be quantitatively assessed for imaging software under MDR?

Question

We are developing imaging software and are struggling with how to quantitatively determine the benefit-risk analysis required under MDR. Specifically, it is difficult to assign a concrete number to the benefits when the benefits are the images or numbers being reported by the software. Are there any recommended methods or standards for quantifying benefit-risk analysis in this context?

Dr. Oliver Eidel · Accepted Answer

You can use several methods to quantify the benefits and risks of software. Here are some common approaches:
• Monetary value: Assign a monetary value to benefits (like cost savings) or risks (such as the financial impact of a data breach).
• Probability: Estimate the likelihood of benefits or risks occurring, for example, the probability of a data breach or user error.
• Severity: Evaluate the potential severity or impact, assigning ratings based on the seriousness of outcomes.

Quantifying benefits and risks using these methods lets you better compare and evaluate the overall benefit/risk profile of your software. Hope this helps!

Answer

The way to approach this is described in ISO 14971:2019, section 7.4. If a residual risk is not judged acceptable using the criteria in your risk management plan and further risk control is not practicable, you can gather and review data and literature to determine if the benefits outweigh the residual risk. In many cases, especially for imaging software, your risk analysis might show that only acceptable residual risks remain. Are you facing any risks that are not acceptable?

How can benefits and risks be quantitatively assessed for imaging software under MDR?

2 Answers

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