Risk management for medical device and ISO 14971 infographic
The whole medical device ISO 14971 risk management process in one picture The ISO 14971 standard is about 90 pages long. What if you could view the whole medical device ISO 14971 risk management process in one picture?! The infographic gives you the overview of risk...
How to Have Successful Risk Management Workshops
Getting started on risk management is sometimes the hardest part. A series of well-thought-out risk management workshops can give you a flying start in your work and allow you to avoid problems at a later stage. And the cost of changes increases the further you have...
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...
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...
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