Regulating Medical Devices in the European Union
The magazine focuses on the development of the ecosystem as well as on selected strengths that in the future can and will characterize our healthcare system in a global perspective.
The highlights of the updated risk management standard
ISO 14971:2019 The highlights of the updated risk management standard Terminology update, most noticeably the definitions: Benefit: Positive impact or desirable outcome of the use of a medical device on the health of an individual, or a positive impact on patient management or public health. State of the art: Developed stage of technical capability at […]
