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Medizintechnik

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Publication DIN Media Kommentar 2024-01

Klinische Prüfung von Medizinprodukten
Kommentar zu DIN EN ISO 14155

It is a legal and moral obligation to thoroughly test medical devices before launching them on the market. DIN EN ISO 14155 provides a reliable framework to ensure high standards and, in particular, the protection of the test subjects involved in the test studies. It meets the principles of good clinical practice with specific content.

from 67.90 EUR VAT included

from 63.46 EUR VAT excluded

Publication DIN Media Kommentar 2023-05

Professionelles Risikomanagement von Medizinprodukten
Ein Leitfaden zur praktischen Umsetzung der DIN EN ISO 14971 im Fokus der MDR- und IVDR-Anforderungen

from 149.00 EUR VAT included

from 139.25 EUR VAT excluded

Medical Products online

Online service 2024-04

Medical Products online
Gesamtpaket der harmonisierten und mandatierten Normen

The contract is renewed for a further year unless it is terminated no less than 3 months before the end of the respective renewal period.

DIN Media offers this product exclusively to customers who are not consumers as defined in § 13 BGB (the German Civil Code).

On subscription only. Purchase implies subscription for at least one year.

Current as of 2024-04

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from 191.00 EUR/Year incl. VAT.

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Publication [PRE-ORDER] Normen-Handbuch 2024-09

Qualitätssicherung an Röntgeneinrichtungen
Richtlinien, Erläuterungen, Normen

approx. price  204.00 EUR VAT included

approx. price  190.65 EUR VAT excluded

Publication DIN Media Pocket 2023-08

FDA Quality System Regulation
FDA Quality System Regulation - 21 CFR Part 820

from 29.80 EUR VAT included

from 27.85 EUR VAT excluded

Publication DIN Media Kommentar 2022-01

Risikomanagement und Biologische Sicherheit von Medizinprodukten
Am Beispiel der biologischen Bewertung und unter Einbeziehung der DIN EN ISO 10993-1 und DIN EN ISO 14971

from 99.00 EUR VAT included

from 92.52 EUR VAT excluded

Publication DIN-Taschenbuch 268 2022-06

Nicht aktive Medizinprodukte
Horizontale Europäische Normen in Anlehnung an entsprechende EU-Richtlinien und -Verordnungen

from 232.00 EUR VAT included

from 216.82 EUR VAT excluded

Publication DIN Media Kommentar 2019-04

Qualitätsmanagement für Hersteller von Medizinprodukten
Praxisleitfaden zur DIN EN ISO 13485 und den neuen EU-Verordnungen

from 86.00 EUR VAT included

from 80.37 EUR VAT excluded

Publication DIN Media Praxis 2020-12

Usability Engineering als Erfolgsfaktor
Effizient DIN EN 62366-1- und FDA-konform dokumentieren

from 82.00 EUR VAT included

from 76.64 EUR VAT excluded

Publication DIN Media Praxis 2016-04

Qualitätsmanagement in der Gesundheitsversorgung nach DIN EN ISO 9001 und DIN EN 15224
Normentext, Erläuterungen, Ergänzungen, Musterformulare

from 98.00 EUR VAT included

from 91.59 EUR VAT excluded

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