Articles

CE-mark a medical device

CE-mark a medical device

If you intend to place a device on the market in an EU or EFTA country, it must be CE marked by you as a manufacturer or part of a registered clinical investigation. CE stands for “Conformité Européenne”. The CE mark means that the product meets the essential...

Risk analysis

Risk analysis is a term often mentioned in relation to risk management and medical devices. The most relevant place for a medical device company to look for an explanation to this term is in the standard ISO 14971, that deals with risk management for medical devices....

Project management

Project management

The word project, and hence the term project management, is both broad and somewhat abused in the sense that the words are used to mean many different things. In some organisations, there is a "project manager" and a "project" as soon as something is done, no matter...

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