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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- EU Regulatory Affairs and Liability Risks of AI-based Medical DevicesManufacturers of medical devices based on artificial intelligence (AI) technologies are facing two major regulatory challenges in Europe: The fulfillment of the fundamental regulatory requirements for medical devices focusing on software and the Integration of special requirements for AI-based devices into the quality management system.
- CE roadmap for medical devices: What are the requirements for approval and what are the costs?Every time a medical device is developed, the question comes up at some point which regulatory requirements have to be fulfilled. If the new medical device is to be marketed in Europe, it requires a CE marking, i.e. the requirements of the European Medical Device Regulation (MDR) apply.
- 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.