Buch, Englisch, 350 Seiten, Format (B × H): 191 mm x 235 mm, Gewicht: 1400 g
FDA-CDRH Manufacturing, Policies and Regulation Handbook
Buch, Englisch, 350 Seiten, Format (B × H): 191 mm x 235 mm, Gewicht: 1400 g
ISBN: 978-0-323-95354-2
Verlag: William Andrew Publishing
Zielgruppe
<p>Regulatory affairs professionals, medical device manufacturers, biomedical engineers working in the field of medical devices.</p> <p>Graduate Master of Science Students in either Regulatory Affairs or Regulatory Science and Law students specializing in Healthcare and Medical Device. </p>
Autoren/Hrsg.
Fachgebiete
- Rechtswissenschaften Ausländisches Recht Westeuropa, Südeuropa
- Technische Wissenschaften Sonstige Technologien | Angewandte Technik Medizintechnik, Biomedizintechnik
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizintechnik, Biomedizintechnik, Medizinische Werkstoffe
Weitere Infos & Material
Section 1: How to Study and Market a Medical Device 1. Overview of Medical Device Regulation 2. Regulatory Routes to Market a Medical Device 3. Premarket Notification 510(k) 4. Device Modifications Requiring new 510(k) Submission 5. Premarket Approval (PMA) 6. Investigational Device Exemption (IDE) 7. In Vitro Diagnostics 8. Clinical Studies for Medical Device 9. Medical Device Labeling 10. FDA Advisory Committees 11. Human Factors and Medical Devices 12. Mobile Medical Applications 13. Software, Cybersecurity and Wireless Coexistence
Section 2: Postmarket Activities and FDA Collaboration 14. Postmarket Activities and Requirements 15. Compliance and Enforcement 16. Quality System Regulation (QRS) 17. Risk Management 18. Meeting and Collaboration with FDA 19. Future of Medical Device Regulation
Appendix A: FDA Guidance Documents (Medical Devices) B: Regulatory Affairs Certification (Devices) Practice Exam Questions C: Quality Management System (QMS) Manual