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).
The FDA sets clear requirements for human factors engineering (HFE) and usability engineering of medical devices. This article provides a comprehensive overview of the FDA’s usability requirements and shows you how to successfully implement them in your product development.
DetailsEU Regulation 2017/745 (MDR) establishes the general requirements for instructions for use (IFU). Whether they can also be provided in electronic form (eIFU) is regulated by Implementing Regulation (EU) 2021/2226. It was revised by Implementing Regulation (EU) 2025/1234. A consolidated version is also available now. We have summarized the requirements for electronic instructions for use for you.
DetailsThe incorporation of AI in medical devices has made great strides, for example, in the diagnosis of disease. Manufacturers of devices with machine learning face the challenge of having to demonstrate compliance of their devices with the regulations. Even if you know the law – what are the standards and best practices to consider in…
DetailsMedical device cybersecurity is a focus not only for the FDA but also for other legislators and authorities, both in the US and other markets. This is understandable The USA has added requirements for cyber devices to the Food, Drug & Cosmetic Act (FD&C), and the FDA has published several guidance documents on cybersecurity, which…
DetailsPractical guidance based on the experience of the Johner Institute, Oliver Hilgers, and Stefan Bolleininger The discussion about class I software continues to rage. This article provides guidance regarding the MDR rules for the classification of medical software.
DetailsSoftware as medical device (SaMD) refers to (independent) standalone software that is a medical device but not part of one. It should not be confused with medical device software as defined by the EU. As a manufacturer, when do you have to qualify software as medical device, and when as medical device software? Find out…
DetailsQM certification refers to the certification of a quality management system (QM system or QMS) by a certification body. The certification confirms to the certified company that its QM system meets a standard (e.g., ISO 9001, ISO 13485) or a law (e.g., MDR, IVDR).
EN ISO 14155:2020 is a standard that has not yet been harmonized for the MDR. It is titled “Clinical investigations of medical devices for human subjects – good clinical practice.” It describes the state of the art for medical device manufacturers in preparing, planning, conducting, and evaluating clinical investigations. It also determines the responsibilities of…
DetailsThe MDR contains the Classification Rule 11. This rule is especially for software. The Rule 11 has serious implications: it bears the potential to further undermine Europe’s innovation capacity. Manufacturers should familiarize themselves with the MDCG‘s interpretation to avoid misclassifying software and to be able to follow the reasoning of notified bodies and authorities. This article…
DetailsBrexit was completed in January 2021. What was a cause for celebration for some means an additional burden for many – including medical device manufacturers. For manufacturers, it is important to understand which regulatory requirements they will have to fulfill and which transition periods they will benefit from if they want to continue selling their…
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.