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Klucze do zgodności medycznej
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ISBN10: 6209453422
ISBN13: 9786209453427
Publisher: Wydawnictwo Nasza Wiedza
Published: Dec 30 2025
Pages: 112
Weight: 0.35
Height: 0.27 Width: 6.00 Depth: 9.00
Language: Polish
ISBN13: 9786209453427
Publisher: Wydawnictwo Nasza Wiedza
Published: Dec 30 2025
Pages: 112
Weight: 0.35
Height: 0.27 Width: 6.00 Depth: 9.00
Language: Polish
Streszczenie - Tom IKeys to medical compliance: from idea to worldwide market launch to zwięzly, przystępny przewodnik pozwalający zrozumiec, w jaki sposób innowacja medyczna staje się bezpiecznym, wysokowydajnym urządzeniem zgodnym z międzynarodowymi wymogami.Książka przedstawia kluczowe standardy - ISO 13485, ISO 14971, ISO 10993, GMP, MDR/IVDR, FDA, IEC 60601, ISO/ASTM 52900 - i wyjaśnia ich rolę w jakości, zarządzaniu ryzykiem, biokompatybilności, produkcji dodatków, cyberbezpieczeństwie i identyfikowalności.Korzystając z konkretnych przykladów (implanty, narzędzia chirurgiczne, oprogramowanie medyczne, pomieszczenia czyste, skanery), śledzi podstawowe etapy zgodności: projektowanie, walidację, testowanie, kontrolę jakości, zarządzanie dokumentacją i certyfikację.Książka podkreśla również wklad sztucznej inteligencji w monitorowanie regulacyjne, zapewnianie jakości i cyberbezpieczeństwo.Poprzez swoje publikacje autor oferuje praktyczne wsparcie studentom, badaczom i przemyslowcom oraz inspiruje nowe pokolenie do postrzegania zgodności nie jako ograniczenia, ale jako prawdziwej dźwigni innowacji, bezpieczeństwa i globalnej konkurencyjności.
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