Stakeholders in the medical device industry
This article presents an overview of different stakeholders and the concept of the economical operators in relation to the MDR. The following video, which is a part of our online course Introduction to the Medical Device Regulation (EU) 2017/745, explains the topic...
UDI requirements for medical device manufacturers in the EU
This article provides a summary of the Unique Device Identifier (UDI) requirements. UDI will be applicable to all manufacturers of medical devices in the EU. If you would like to know more about the UDI requirements, please take a look at the video below. The video is...
Clinical investigation and clinical evaluation of medical devices
Clinical research is necessary to develop new treatments for different diseases and conditions that occur in humans. To develop these new treatments, clinical trials have to be performed to get proof that the new treatment works and that it is safe. The video below...
The scope and purpose of SOPs and controlling documents
This article is aimed at people working with quality management systems since it will present how to create controlling documents that are essential for QMS. It will focus on purpose and scope which may seem simple at a first glance. And sure enough, writing a purpose...
What is new in the IEC 62366-1 AMD1:2020?
In June 2020, the IEC 62366-1 standard underwent some updates. The video below will go over the main changes between the new and old versions of the standard. The video is an excerpt from the online course Introduction to Usability Engineering and IEC 62366-1. If you...
Medical Device HQ
In-house training, public and online courses on managing and developing safe medical devices
