Navigating the FDA 510(k) Process - E-book - ePub

Edition en anglais

Note moyenne 
 Dr. Nilesh Panchal - Navigating the FDA 510(k) Process.
"Navigating the FDA 510(k) Process: A Comprehensive Guide to Premarket Success" is an essential resource for medical device manufacturers and innovators... Lire la suite
27,99 € E-book - ePub
Vous pouvez lire cet ebook sur les supports de lecture suivants :
Téléchargement immédiat
Dès validation de votre commande
Offrir maintenant
Ou planifier dans votre panier

Résumé

"Navigating the FDA 510(k) Process: A Comprehensive Guide to Premarket Success" is an essential resource for medical device manufacturers and innovators looking to bring their products to market in the U. S. This guide provides a step-by-step roadmap through the FDA's 510(k) premarket notification process, offering detailed insights into device classification, substantial equivalence, testing requirements, and submission strategies.
It covers everything from preparing a strong application to avoiding common pitfalls, navigating third-party reviews, and ensuring post-market compliance. With real-world case studies and expert tips, this book equips readers with the knowledge and tools to achieve successful 510(k) clearance and ensure regulatory success.

Caractéristiques

  • Date de parution
    03/10/2024
  • Editeur
  • ISBN
    8227884510
  • EAN
    9798227884510
  • Format
    ePub
  • Caractéristiques du format ePub
    • Protection num.
      pas de protection

Avis libraires et clients

Avis audio

Écoutez ce qu'en disent nos libraires !

À propos de l'auteur

Biographie de Dr. Nilesh Panchal

Dr. Nilesh Panchal is a distinguished Public Health Practitioner and Health Scientist with over two decades of experience, making significant contributions to the fields of infectious diseases, mental health, and public health education. Holding a DrPH in Public Health Practice, Dr. Panchal is a prolific author known for his ability to translate complex medical concepts into accessible and engaging content for a broad audience.
His work, including the acclaimed series "Global Outbreaks: The Saga of Humanity's Health Battles, " provides invaluable insights into the challenges posed by infectious diseases, making it an authoritative source for understanding humanity's ongoing battle against deadly pathogens. Dr. Panchal's dedication to educating the public extends to his "Mindfulness and Well-Being Series, " where his compassionate and practical approach empowers readers to enhance their mental and emotional well-being.
In addition to his focus on infectious diseases and mental health, Dr. Panchal has made remarkable strides in lifestyle medicine, particularly in the prevention of diabetes. His book series "Healthy Living, Healthy Future: Diabetes Prevention Series" offers evidence-based strategies that empower individuals to make lasting lifestyle changes for a healthier, diabetes-free life. Dr. Panchal's commitment to public health is also reflected in his guide "Essential First Aid: Life-Saving Techniques for Everyone, " where he provides clear, step-by-step instructions for managing emergencies.
Through his extensive research, Dr. Panchal continues to be a respected voice in global health, contributing to medical journals, speaking at international conferences, and leading health innovation projects aimed at integrating AI into clinical practice. His body of work not only informs but also inspires, making a lasting impact on global health practices and public education.

Souvent acheté ensemble

Vous aimerez aussi

Derniers produits consultés

Navigating the FDA 510(k) Process est également présent dans les rayons

27,99 €