Category: Uncategorized
Probenahme-Sets aus regulatorischer Sicht
Den Begriff „Probenahme-Set“ definiert weder die IVDR noch eine andere Regularie. Dennoch gibt es (indirekte) regulatorische Anforderungen, die IVD-Hersteller und medizinische Labore kennen und beachten müssen. Die Anforderungen hängen von der jeweiligen Konstellation ab. Dieser Artikel stellt fünf Konstellationen vor. Er verschafft damit Klarheit und hilft, regulatorischen Ärger zu vermeiden und regulatorische Aufwände zu minimieren.…
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Simply irresistible air fryer apple pies
Whether it’s a family party or a festive gathering, one thing is for sure: warm, flaky homemade pies are always a crowd pleaser. If you’re looking for a fun twist on tradition, try these irresistible air fryer apple pies. They’ll be ready in minutes and are super easy to serve, making them perfect for parties…
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Test di regressione: la tua assicurazione software
I tester del software solitamente intendono un test di regressione come la ripetizione di un test esistente. Vuoi verificare se questo test funziona ancora con successo dopo una modifica del software. Leggi questo articolo su cosa dovresti considerare quando conduci un test di regressione per un software medico. 1. Obiettivi dei test di regressione Obiettivo…
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Give your home a festive scent with slow cooking for the holidays
A slow cooker is an easy way to infuse your home with the warm, inviting scents of the season. Gather just a handful of ingredients like oranges, cinnamon, cloves, ginger and apple juice, place them in the Hamilton Beach® slow cooker and enjoy this all-natural air freshener, perfect for the most wonderful time of the…
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Healthcare IT and medical technology jobs
We treat all inquiries relating to job offers and job applications with absolute confidentiality. You can communicate via us or directly with the specified contact persons. July 2024 Neuroloop Neuroloop, a subsidiary of Aesculap AG, is looking for a Senior Regulatory Affairs Manager for the Freiburg office. Bausch + Lomb | Perfect vision of Technolas…
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Why you need a hand mixer for the holidays
As the holiday season approaches, so will your kitchen they will probably become a vibrant hub of friends, family and culinary creativity. That is because you need a trusted companion to help you tackle tasks with ease. Here you are where the humble hand mixer comes into play. This unsung holiday hero is the ultimate…
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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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