The Covid-19 situation from a medical device risk management perspective
There are many ongoing discussions about the economic effects of the lockdown that many countries have been subject to with regards to the Corona virus. In this article, I have applied a medical device risk management perspective on the Covid-19 situation to explore...
How to work with medical device risk management
Working with risk management can be tricky, but the following video offers six useful tips on how to get the desired results in the best way. It is a part of our online course on Risk management for medical devices and IEC 14971:2019. This article aims to give tips...
Risk management for medical device and ISO 14971:2019 infographic
The whole medical device ISO 14971 risk management process in one picture The ISO 14971:2019 standard is quite 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...
Where to buy and download the ISO 14971:2019 standard as PDF
The fastest and cheapest way to get hold of a (legal and therefore not free) copy of the ISO 14971:2019 standard 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...
How to estimate risk
The most common question I get when delivering courses on risk management and ISO 14971:2019 is how you should be estimating risk. It is something that many of us have to do when we take part in risk management.I will share with you how it’s supposed to be done, and...
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