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).
Trend analysis is a legal obligation of all medical device manufacturers, especially in “Post-Market Surveillance.” Manufacturers must not fail in the selection and application of suitable statistical methods for trend analysis. This is because the focus of authorities and notified bodies is increasingly shifting to monitoring post-market activities. This article provides a quick introduction to this…
DetailsThe term “medical device PC” is not clearly defined. However, most people understand a medical device PC to be Depending on the constellation, manufacturers must fulfill different regulatory requirements. These are presented in this article. 1. Case distinctions for medical device PCs Case A: Standalone software is delivered If you as a manufacturer only supply…
DetailsMedical device certification, MDR certification, CE certification. These are terms that are used frequently. But is there even such a thing as medical device certification? This article answers the question. 1. Summary The short answer is: There is no formal medical device certification, CE certification, or MDR certification. However, manufacturers do require certifications or certificates.…
DetailsIEC 80001-1 has the long title “Application of risk management for IT-networks containing medical devices – Part 1: Tasks, responsibilities and activities“. This article reveals what the standard requires and why manufacturers should also consider it. 1. About DIN EN IEC 80001-1 a) Objectives of DIN EN IEC 80001-1 The standard aims to help minimize…
DetailsSwitzerland is important both as a manufacturing location and as a market for medical device manufacturers who are based outside Switzerland. However, since May 26, 2021 (for medical devices) and May 26, 2022 (for in vitro diagnostic devices | IVD medical devices), manufacturers from Switzerland as well as manufacturers from other markets (e.g., the EU)…
DetailsPeople often talk about the approval of medical devices, even if something else is meant – sometimes a certificate of conformity, sometimes a “clearance,” sometimes a successfully completed conformity assessment procedure. Terms like “MDR approval” are even misleading. This article clarifies what a medical device approval means and when manufacturers need one in the first…
DetailsInternal audits are inspections of the quality management system (QM system) and its processes by the organization itself. This is why they are also called 1st party audits. ISO 13485 requires internal audits like its “sister standard,” ISO 9001, and other standards and regulations. Therefore, internal audits are also a subject of external audits and…
DetailsWhether risk mitigation through information is permitted regularly leads to discussions. The answer to this question is important because it determines the conformity and non-conformity of medical devices. This article provides the answer and thus resolves a “historical misunderstanding.” 1. Regulatory framework All manufacturers are obliged to minimize the risks posed by their medical devices.…
DetailsSince May 25, 2017, the In Vitro Diagnostic Medical Device Regulation (IVDR) has been in force, which has now replaced the previous IVD Directive (98/79/EC, IVDD). There are significant differences between the IVDR and IVDD. This article presents these differences. In doing so, it provides manufacturers who placed their devices under the EU directive (IVDD)…
DetailsLaws and standards formulate requirements on how medical device manufacturers must define and document the development process. Notified bodies check these requirements during audits. This article on the development process provides tips on how to design the process and how to align it with other processes, such as the risk management process. 1. Development process:…
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.