Performing medical device risk evaluation
Perhaps the easiest part of risk management is risk evaluation. Still, one needs to know how to do it properly to perform risk management successfully. The following topic is a part of our online Introduction to risk management and ISO 14971:2019 course. You can...
What is not mentioned in IEC 62366-1
One of the most underestimated aspects of being a usability engineer is the mindset. To maybe no surprise, “mindset” is not mentioned in the IEC 62366-1 standard in usability engineering. The following video, which is a part of our online Introduction to usability...
The perfect project process for medical device product development
Having the right project process can be key in developing products in as short time as possible and at a low cost as possible while still meeting regulatory requirements.It can allow you to exercise control over projects, especially in a multi-project environment. A...
How to get the EN ISO 14155:2020 standard – download and buy as PDF
Anyone involved with clinical investigation should have a copy of the ISO 14155:2020 standard because it contains everything that is needed on good clinical practice, GCP. But it can be expensive if you buy it in the wrong place.In this article, you will learn where...
EUDAMED logins for beginners
The aim of this article is to give an in-depth explanation of how to perform EUDAMED login. You may want to know how to complete all the steps to register as an actor within the database, or simply to search for the information you need. The video below is a part of...
Medical Device HQ
In-house training, public and online courses on managing and developing safe medical devices