Comparing the least expensive version with the most expensive ones will result in a price difference of 1400%. The price at the Estonian Centre for Standardisation is significantly lower than the others. Find out where to buy and download the standard.
In June 2020, the IEC 62366-1 standard underwent some updates – Let us look at the eight most important changes in the AMD1:2020 in order of importance.
Usability engineering and risk management are connected in many ways, and all steps should be taken to ensure both safe and user-friendly medical devices for the end users.
Summative evaluation is the final evaluation of your product’s user interface and confirmation that it does not result in an unacceptable risk to people. Essentially, it is the stage where you get to see if your whole usability engineering process was successful.
The instructions for use is not only something which is referred to in many ways, such as user guide, operating manual or labelling. It is also a document which can be instrumental in achieving safety for a medical device.
Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course.
These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.
Special launch offer: 349 299 EUR for the online plan & 449 349 EUR for the online lifetime plan.