Category: Uncategorized
The FDA eStar Program: Obligation or Opportunity?
With the eStar program The FDA wants to increase the efficiency of approval processes (e.g. the 510(k) process) through digitalization. The Johner Institute is working with the FDA to further develop eStar. In this article you will find out how far-sighted this approach is and whether you should or even need to take part in…
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ISO 15223-1: Medical symbols and markings
ISO 15223-1 regulates the symbols that manufacturers can (or must) use to label medical devices. In January 2022, the EU Commission harmonized EN ISO 15223-1 as one of the relatively few standards under the MDR and added it to the list of harmonized standards. This alone makes it clear how relevant labeling has become. Read…
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Electronic instructions for the use of medical devices
EU Regulation 2017/745 (MDR) specifies the general requirements for instructions for use (IFU for short). The Implementing Regulation (EU) 2021/2226 regulates whether it can also be available in electronic format (eIFU). We have summarized the requirements of the electronic operating instructions for you. 1. Requirements for using the electronic operating instructions According to Implementing Regulation…
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Everything you need to know
The European one Medical Devices Regulation MDR (EU Regulation on Medical Devices) must be taken into consideration by manufacturers intending to market medical devices in the EU. This Regulation (EU) 2017/745 on medical devicesthe official title, also imposes requirements on notified bodies, traders, importers and healthcare facilities such as hospitals. … for beginners If you…
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Gebrauchsanweisungen für Medizinprodukte
Mangelhaft gestaltete Gebrauchsanweisungen sind häufig Ursache für Benutzungsfehler, welche zu Schäden bei Patienten und Anwendern führen können. Zudem unterliegen Gebrauchsanweisungen für Medizinprodukte und IVD strengen regulatorischen Anforderungen. MDR, IVDR, die FDA sowie zahlreiche Normen stellen spezifische Anforderungen an Gebrauchsanweisungen. In diesem Artikel erfahren Sie, wie Sie eine Gebrauchsanweisung schreiben, die hilft, Schäden bei Patienten, Anwendern…
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Unit Testing und IEC 62304
Unter Unit-Testing wird in der Software-Entwicklung das Testen von Software-Units verstanden. Allerdings gibt es weder ein einheitliches Verständnis darüber, was eine Software-Unit ist, was einen guten Unit-Test auszeichnet und welche regulatorischen / gesetzlichen Anforderungen erfüllt werden müssen. Dieser Artikel verschafft Klarheit. 1. Testobjekte: Was beim Unit-Testing getestet wird a) Übliches Verständnis von Software-Units Beim Unit-Testing…
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Grilled Taco Skewers – Hamilton Beach
Enjoy a feast of flavors combining the savory goodness of grilled skewers with the spicy crunch of tacos. This surprisingly simple recipe features succulent, perfectly seasoned chicken, beef or pork and a variety of colorful peppers and other vegetables, all grilled to perfection on a Hamilton Beach® indoor electric grill for a feast that promises…
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Systeme und Behandlungseinheiten aus Medizinprodukten
Die europäische Gesetzgebung definiert Systeme und Behandlungseinheiten („systems and procedure packs“) und unterscheidet verschiedene Konstellationen. Die regulatorischen Anforderungen an die Hersteller hängen stark von diesen Konstellationen ab. Lesen Sie in diesem Artikel, was die Gesetzgeber unter Systemen und Behandlungseinheiten verstehen, was die wichtigsten gesetzlichen Anforderungen an die Hersteller sind und welche typischen Fehler sie vermeiden…
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How to Grill a Great Steak on an Indoor Grill
You don’t have to go outdoors and fire up the grill every time you feel like a steak dinner. If it’s too cold or you want the convenience of being in the kitchen among utensils, condiments and dinner companions, rely on the convenience and versatility of an indoor grill. Master the indoor grilling method Indoor…
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Document Control ~ Software, QM ~ Document Control
Under Document control it is a documented process that determines how documents are created, reviewed, approved, labeled, distributed and updated. Organizations certified according to ISO 9001 or ISO 13485 are obliged to maintain document control. 1. Object of the document control It is obvious that document control is about documents. What is less obvious is…
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