Discover new articles every week on the topics of regulatory affairs (including international approval and FDA approval), QM systems (e.g., ISO 13485), risk management (ISO 14971), software development (IEC 62304), IT security, clinical evaluation, usability engineering (IEC 62366-1), and systems engineering (including IEC 60601-1, ISO 10993) - also for IVD medical devices.
Please note the pages for managers and beginners or filter by keywords (tags).
For manufacturers, the answer to whether and when clinical studies are necessary when using artificial intelligence in medical devices is relevant. After all, the duration and cost of bringing these devices to market depend on this. The good news in advance: there are cases where manufacturers can avoid clinical studies for devices with AI. This…
DetailsThe EU plans to replace the existing Directive 2006/66/EC with the new EU Regulation on batteries and waste batteries (“Battery Regulation”). This article clarifies,
DetailsCombination products consist of the combination of a medical device and a medicinal product. Since both medical device and medicinal product law could be applicable here, there are some special features that must be taken into account for products of this type. In this article, you learn more about
DetailsThe FDA describes its requirements for Human Factors Engineering in two documents: This article
DetailsIn order to evaluate the biocompatibility of standard materials, medical device manufacturers can, in most cases, avoid animal testing. In recent years, the Johner Institute had always succeeded in showing alternatives to animal testing, even when authorities and notified bodies demanded them. Learn here how you can contribute to animal welfare, save money, and bring…
DetailsA German medical technology industry analysis from 2020 estimated the market for medical devices in South Korea at USD 6.7 billion. Due to an annual growth rate of imports of (estimated) 10% and the increasing aging of the population with a simultaneous increase in basic medical care, the South Korean market is expected to grow…
DetailsOnly through clinical evidence – real evidence – can manufacturers prove their medical devices’ safety, performance, and benefit. But when is proof valid enough? In other words, when is there sufficient clinical evidence for authorities and notified bodies to accept? This article answers the questions and provides a compact introduction to the topic of “clinical…
DetailsEUDAMED is the European database for medical devices. However, it is not only used to manage medical devices. The Medical Device Regulation (MDR) relies on EUDAMED and determines which requirements must be stored in this database. These regulations affect the work of manufacturers and also the work of authorities and notified bodies.
DetailsThis article describes when and why manufacturers must affix a CE mark, what is meant by CE marking, and what manufacturers must do up to that point.
The QM manual is the top document in the document pyramid of the QM system. It is an entry point for employees and auditors to get a quick overview of the QM system. In this article, you will learn when you need a QM manual, its objectives, and what it should contain.
Details
Privacy Preference
We need your consent before you can continue on our website. If you are under 16 and wish to give consent to optional services, you must ask your legal guardians for permission. We use cookies and other technologies on our website. Some of them are essential, while others help us to improve this website and your experience. Personal data may be processed (e.g. IP addresses), for example for personalized ads and content or ad and content measurement. You can find more information about the use of your data in our privacy policy. You can revoke or adjust your selection at any time under Settings.
Privacy Preference
If you are under 16 and wish to give consent to optional services, you must ask your legal guardians for permission. We use cookies and other technologies on our website. Some of them are essential, while others help us to improve this website and your experience. Personal data may be processed (e.g. IP addresses), for example for personalized ads and content or ad and content measurement. You can find more information about the use of your data in our privacy policy. Here you will find an overview of all cookies used. You can give your consent to whole categories or display further information and select certain cookies.