May 18, 2022 | Articles, Clinical investigation ISO 14155 |
The ISO 14155 standard has undergone some changes in its 2020 edition. This article will present them, and the video below offers an insight into the major changes compared to the previous version of the standard. The video is a part of our online course Introduction...
May 16, 2022 | Articles, Medical device regulation |
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...
May 12, 2022 | Articles, Medical device regulation |
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...
May 10, 2022 | Articles, Clinical investigation ISO 14155 |
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...
Mar 2, 2022 | Articles, Quality management ISO 13485 |
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...
Feb 22, 2022 | Articles, Usability engineering 62366-1 |
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...