FMEA and risk management according to ISO 14971

FMEA and risk management according to ISO 14971

Risk management vs FMEA Risk management for medical devices is a comprehensive approach, including requirements for planning the development of a device, to the requirements for a device that is no longer on the market. Even though the standard in application of risk...
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...
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...