Where to buy and download the ISO 14971 standard as PDF
The fastest and cheapest way to get hold of a (legal and therefore not free) copy of the ISO 14971 on Risk Management is to purchase it from a web-store and download it as a pdf. But the prices may vary greatly depending on where you choose to buy the standard. Below...
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...A short introduction to risk analysis and FMEA for medical devices
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
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...
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