With the eSTAR Program, the FDA aims to increase the efficiency of approval procedures (e.g., the 510(k) procedure) through digitalization. This article tells you how forward-looking this approach is and whether you should or even must take part. 1. What is the eSTAR Program? The eSTAR Program enables medical device manufacturers to submit their approval…
DetailsThe FDA describes its requirements for Human Factors Engineering in two documents: This article What the FDA calls “Human Factors Engineering” (HFE), IEC 62366-1 calls “Usability Engineering“. The FDA defines the term as follows: 1. How the FDA’s “Human Factors Guidances” interact In the introduction to the document “Content of Human Factors Information in Medical…
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. 1. Which purpose…
DetailsThe 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. 1. QM manual:…
DetailsIn a Standard Operating Procedure (SOP), companies define their processes, for example how they develop medical devices or provide services. Standards such as ISO 9001 and ISO 13485 require Standard Operating Procedures. Companies can define these specifications in their quality management manual directly or in independent documents. 1. Standard Operating Procedures: introduction, definitions a) Definition ISO…
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. 1. Regulatory requirements a) Requirements of ISO 13485 The requirements of ISO…
DetailsA design change is a change in the design of a product. It is important to understand what regulatory implications arise from this and where there may be an impact on the validity of the product’s declaration of conformity. This article provides an overview and thus resolves many currently common misconceptions. 1. Design change: What it means…
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