FDA and Intellectual Property Strategies for Medical Device Technologies

• Κύριοι συγγραφείς: Halt, Gerald B. (Συγγραφέας, http://id.loc.gov/vocabulary/relators/aut), Donch, John C. (http://id.loc.gov/vocabulary/relators/aut), Stiles, Amber R. (http://id.loc.gov/vocabulary/relators/aut), VanLuvanee, Lisa Jenkins (http://id.loc.gov/vocabulary/relators/aut), Theiss, Brandon R. (http://id.loc.gov/vocabulary/relators/aut), Blue, Dana L. (http://id.loc.gov/vocabulary/relators/aut)
• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Cham : Springer International Publishing : Imprint: Springer, 2019.
• Έκδοση: 1st ed. 2019.
• Θέματα: Biomedical engineering.; Electronics.; Microelectronics.; Engineering economics.; Engineering economy.; Biomedical Engineering and Bioengineering.; Electronics and Microelectronics, Instrumentation.; Engineering Economics, Organization, Logistics, Marketing.

This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the fir...

Πίνακας περιεχομένων:

• Introduction
• Development of A New Medical Device
• Determining If A Medical Device Technology Is FDA Regulated
• Basic FDA Regulatory Requirements For Medical Devices
• Other Regulatory Consideration For Medical Devices
• Benefits of Having FDA Approval
• Patents
• Trademarks and Trade Dress
• Trade Secrets
• Copyrights In Medical Device Technology
• Design Protection For Medical Devices
• Intellectual Property Issues in Medical Device Labeling and Marketing
• Enforcement, Infringement and Monetization of Intellectual Property Rights
• Successful Implementation of a Medical Device Company's IP Strategy
• Tips for Avoiding and Preventing Intellectual Property Problems
• Successful Implementation of a Medical Device Company's Regulatory Strategy
• Tips for Avoiding and Preventing Regulatory Problems
• Potential Combined IP and Regulatory Pitfalls.