Inicio > Tecnología, ingeniería, agricultura > Tecnología: cuestiones generales > Chaves para a conformidade médica
Chaves para a conformidade médica

Chaves para a conformidade médica

CHERIF GHEBACHE

93,68 €
IVA incluido
Disponible
Editorial:
KS OmniScriptum Publishing
Año de edición:
2025
Materia
Tecnología: cuestiones generales
ISBN:
9786209455988
93,68 €
IVA incluido
Disponible

Selecciona una librería:

  • Librería Samer Atenea
  • Librería Aciertas (Toledo)
  • Kálamo Books
  • Librería Perelló (Valencia)
  • Librería Elías (Asturias)
  • Donde los libros
  • Librería Kolima (Madrid)
  • Librería Proteo (Málaga)
Sobre IBD

Resumo - Volume IChaves para a conformidade médica: da ideia ao lançamento no mercado global é um guia conciso e acessível para compreender como uma inovação médica se torna um dispositivo seguro e de alto desempenho que cumpre os requisitos internacionais.O livro apresenta as principais normas - ISO 13485, ISO 14971, ISO 10993, GMP, MDR/IVDR, FDA, IEC 60601, ISO/ASTM 52900 - e explica o seu papel na qualidade, gestão de riscos, biocompatibilidade, fabrico de aditivos, cibersegurança e rastreabilidade.Recorrendo a exemplos concretos (implantes, instrumentos cirúrgicos, software médico, salas limpas, scanners), traça as etapas essenciais da conformidade: conceção, validação, ensaios, controlo de qualidade, gestão de documentos e certificação.O livro também destaca a contribuição da inteligência artificial para o controlo regulamentar, a garantia de qualidade e a cibersegurança.Através das suas publicações, o autor oferece apoio prático a estudantes, investigadores e industriais e inspira uma nova geração a encarar a conformidade não como um constrangimento, mas como uma verdadeira alavanca para a inovação, a segurança e a competitividade global.

Artículos relacionados

  • Science and the Big Issues of Our Time
    Martin Gellender
    Within the last few generations, our world has been shaped by technological change enabled by scientific advances. This is particularly evident to the 'baby boomer' generation, who have lived through and witnessed huge changes in society over the course of their lifetimes. Although many have little education in science, or have forgotten what they learned in high school, they u...
    Disponible

    26,58 €

  • Statics+++
    James W Dally / Robert J Bonenberger
    This textbook has been prepared to support a course offering for Statics at the University of Nevada at Reno.  Statics provides the first exposure of engineering students to the study of mechanics.  While Statics is a relatively simple subject, many students find it difficult, and they often perform far below our expectations.  In an effort to improve the curriculum, several me...
    Disponible

    101,22 €

  • Technical Writing, Presentational Skills, and Online Communication
    Raymond Greenlaw
    This book addresses four main topics: professional ethics, technical writing, presentation skills, and online writing. These topics are woven throughout the book and some of them are the main subjects of one or more chapters. The overarching theme of this book is to provide well-tested, best-practice techniques and strategies for main topic areas while focusing on information t...
  • Project Management Techniques and Innovations in Information Technology
    John Wang
    Managing cost, time, and quality of a project can be a challenging task for any project manager, but especially in times of an ever-changing and burgeoning field of IT. Project Management Techniques and Innovations in Information Technology offers a vital compendium of the latest research, case studies, best practices, and methodologies within the field of IT project management...
  • Phenomenology, Organizational Politics, and IT Design
    Information systems are researched, published on, and utilized as an extremely broad and vital sector of current technology development, usually studied from the scientific or technological viewpoints therein. Phenomenology, Organizational Politics, and IT Design: The Social Study of Information Systems offers a new look at the latest research and critical issues within the fie...
  • Geotechnical Applications for Earthquake Engineering
    Disaster preparedness and response management is a burgeoning field of technological research, and staying abreast of the latest developments within the field is a difficult task. Geotechnical Applications for Earthquake Engineering: Research Advancements has collected chapters from experts from around the world in a variety of applications, frameworks, and methodologies, and p...

Otros libros del autor

  • Schlüssel zur medizinischen Compliance
    CHERIF GHEBACHE
    Zusammenfassung - Band ISchlüssel zur medizinischen Konformität: Von der Idee bis zur weltweiten Markteinführung ist ein synthetischer und leicht zugänglicher Leitfaden, um zu verstehen, wie eine medizinische Innovation zu einem sicheren, leistungsfähigen und den internationalen Anforderungen entsprechenden Produkt wird.Das Buch stellt die wichtigsten Normen vor - ISO 13485, IS...
    Disponible

    93,65 €

  • Keys to medical compliance
    CHERIF GHEBACHE
    Summary - Volume IKeys to medical compliance: from idea to global market launch is a concise, accessible guide to understanding how a medical innovation becomes a safe, high-performance device that complies with international requirements.The book presents the key standards - ISO 13485, ISO 14971, ISO 10993, GMP, MDR/IVDR, FDA, IEC 60601, ISO/ASTM 52900 - and explains their rol...
    Disponible

    93,56 €

  • Clés de la conformité médicale
    CHERIF GHEBACHE
    Resumen - Volumen IClaves de la conformidad médica: de la idea al lanzamiento al mercado mundial es una guía concisa y accesible para entender cómo una innovación médica se convierte en un dispositivo seguro y de alto rendimiento que cumple los requisitos internacionales.El libro presenta las normas clave -ISO 13485, ISO 14971, ISO 10993, GMP, MDR/IVDR, FDA, IEC 60601, ISO/ASTM...
    Disponible

    93,68 €

  • Chiavi della conformità medica
    CHERIF GHEBACHE
    Sommario - Volume ILe chiavi della conformità medica: dall’idea al lancio sul mercato globale è una guida concisa e accessibile per capire come un’innovazione medica diventa un dispositivo sicuro, ad alte prestazioni e conforme ai requisiti internazionali.Il libro presenta gli standard principali - ISO 13485, ISO 14971, ISO 10993, GMP, MDR/IVDR, FDA, IEC 60601, ISO/ASTM 52900 -...
    Disponible

    93,68 €

  • Klucze do zgodności medycznej
    CHERIF GHEBACHE
    Streszczenie - Tom IKeys to medical compliance: from idea to worldwide market launch to zwięzły, przystępny przewodnik pozwalający zrozumieć, 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...
    Disponible

    93,65 €

  • Clés de la conformité médicale
    CHERIF GHEBACHE
    Résumé - Tome IClés de la conformité médicale : de l’idée à la mise sur le marché mondial est un guide synthétique et accessible pour comprendre comment une innovation médicale devient un dispositif sûr, performant et conforme aux exigences internationales.L’ouvrage présente les normes clés - ISO 13485, ISO 14971, ISO 10993, GMP, MDR/IVDR, FDA, IEC 60601, ISO/ASTM 52900 - et ex...
    Disponible

    93,60 €