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.
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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…
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.
DetailsThe Quality Management Representative (QMR) is also called the quality representative or “management representative” by ISO 13485. In this article, you will learn which tasks the person with this role is responsible for within an organization and which regulatory requirements must be observed.
DetailsBoth the MDR and the IVDR require a “person responsible for regulatory compliance” (PRRC). Some people also call them the “article 15 person” (after the corresponding articles in the two EU regulations) or the “qualified person”. The terms “person responsible for compliance with regulatory requirements” (abbreviated to “person responsible”) and “qualified or competent person” are used in German. The “person…
DetailsPMCF studies are studies that manufacturers use as part of Post-Market Clinical Follow-up (PMCF) to continuously demonstrate compliance of their medical devices. Manufacturers do not always need to conduct studies to meet PMCF requirements. And not all types of PMCF studies are subject to MDR requirements. This article compactly summarizes the regulatory requirements in the…
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