Month: June 2024
CAPA: Korrekturmaßnahmen, Vorbeugungsmaßnahme
Was MDR und IVDR verwechseln und weshalb Sie nicht von CAPA sprechen sollten Die FDA (im 21 CFR part 820 – QSR) und die ISO 13485 unterscheiden Korrekturmaßnahmen (corrective actions), Vorbeugungsmaßnahmen (preventive actions) und Korrekturen (corrections). Leider unterscheiden die MDR und die IVDR diese Konzepte nicht präzise. Auch viele Hersteller glauben, „corrective and preventive actions“ zu einem CAPA-Prozess zusammenfassen zu…
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The definitive recipe for the green power smoothie
There are many ways to fuel your day with your favorite vegetables. Whether it’s a kale salad, sweet and tangy kale, or matcha muffins, greens aren’t just pretty; they can also be delicious and nutritious. If you’re looking for a simple yet satisfying way to fill up on the goodness of veggies, try this simple…
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Understand and avoid deviations and non-compliance
Deviations, non-conformities, errors, findings and other terms are often mistakenly used synonymously. The standards also explicitly contradict each other when defining individual terms. This article clarifies how the terms should be understood, what are the causes and consequences of non-conformities e how medical device manufacturers can avoid these deviations and non-compliances. 1. Non-compliance: basics 1.1…
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7 easy recipes to celebrate Mother’s Day
Show mom your love and appreciation on Mother’s Day by preparing a memorable breakfast or brunch at home. Whether she likes to start the day healthy with a smoothie or prefers to indulge in the rich flavors of stuffed French toast or cinnamon bread pudding, there’s a recipe to suit every mum and satisfy all…
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Diner-style breakfasts made easy to make at home
Sizzling bacon, golden pancakes and eggs cooked just the way you like them: this classic restaurant breakfast isn’t just a meal; it’s a family tradition full of feel-good weekend vibes. With the Hamilton Beach® Professional Cast Iron Electric Grill, you can skip the trip to the restaurant down the road and easily recreate the best…
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Übergangsfristen der MDR: Endlich verständlich. Mit Merkblatt!
Die MDR legt in Artikel 120 die Übergangsbestimmungen einschließlich der Übergangsfristen fest. Allerdings sind diese Übergangsbestimmungen und Übergangsfristen sehr komplex formuliert. Daher laufen die Hersteller Gefahr, sie falsch zu verstehen und regulatorische Anforderungen nicht zu erfüllen oder unnötige Aufwände zu betreiben. Ein Ablaufdiagramm in Kapitel 2 dieses Artikels fasst die regulatorischen Anforderungen zusammen und schafft…
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7 Ways to Prevent Windows Explorer from Crashing
File Explorer (also known as Windows Explorer) is the default file manager in Windows, but it can do much more. The Explorer.exe process is responsible for displaying the user interface such as the Start menu, desktop icons, etc. If Explorer crashes, your computer experience will not be pleasant. If you don’t know why File Explorer…
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