ISO 14971 is assigned to the medical technology sector and is entitled “Medical devices – Application of risk management to medical devices”. It describes the risk management process for medical devices and is internationally applicable.
A medical device is used in or on humans and involves a certain degree of risk. In order to ensure a uniformly high level of protection, guidelines have been issued by the European Union and the FDA, among others. These guidelines govern the marketing and safe operation of medical devices.
This is associated with a large number of standards and legal requirements that must be observed by medical and pharmaceutical companies. We support you!
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