Liability describes the legal responsibility for one’s actions and products. In terms of medical software product liability is of particular interest.
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- Regulatory Affairs for AI Applications in Medical DevicesThe use of AI blurs the determination of classic software products because the training data alters the algorithm. Hence, all stakeholders are facing new challenges: the potentially continuing modifications as well as being very much depended on carefully selected training data. Therefore, currently AI algorithms need to be implemented in a frozen state in medical devices to receive clearance for US or EU market access.
- Medical apps or software: classification and approval as medical deviceSoftware like a medical app that has a medical purpose is legally a medical device. This article gives an overview of the path from a software to a medical device with CE-marking.
- Risk Management for Medical Devices: ISO 14971The risks of a medical device must be acceptable in comparison to its benefits. Manufacturers must therefore carry out a risk management process.
- Product Liability and Medical Software: Fortunately You Can Insure YourselfSoftware can be a medical device. This has considerable consequences for product liability. The good news: manufacturers can manage the risks.
- Harmonized Standards for Medical SoftwareHarmonized standards are the first choice to achieve conformity with the EU MDR, but not all requirements are always covered.