Medical Device Regulations: A Complete Guide - Softcover

Deep, Aakash

Softcover

ISBN 10: 0323911269 ISBN 13: 9780323911269

Verlag: Academic Press, 2022

Inhaltsangabe

Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety.

The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements.

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Über die Autorin bzw. den Autor

Dr. Aakash Deep is currently working as an Assistant Professor in the Department of Pharmaceutical Sciences at Chaudhary Bansi Lal University, Bhiwani. Dr. Deep was awarded B. Pharm. degree from Kurukshetra University, Kurukshetra (2006), and M. Pharm. in Pharmaceutical Chemistry from Guru Jambheshwar University of Science & Technology, Hisar (2008). He received his PhD degree in pharmaceutical sciences from Maharshi Dayanand University, Rohtak (2015). Dr. Deep was awarded Junior Research Fellowship and Senior Research Fellowship from University Grant Commission, New Delhi, and was awarded the Best Thesis Award for the good work in PhD. Dr. Deep is a recipient of the Young Pharmacy Teacher Award, 2016 by APTI, Haryana State Branch and Best Thesis Award (2015–16) by Maharshi Dayanand University, Rohtak.

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Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. It also covers the registration procedures of medical devices for pharmaceutical regulatory organizations. It will help readers to deliver safe and effective healthcare products to market globally. Pharmaceuticals and Medical devices are one of the most highly regulated industries worldwide and navigating the different countries regulatory requirements can be complex. This book offers an easy to understand compendium of medical device regulations from the most strictly regulated countries, guiding the reader through a holistic design process.

Medical Device Regulations: A Complete Guide provides guidance on dealing with the ethical considerations of medical device development, and compliance with patient confidentiality using information from medical devices. It also covers interoperability between and among devices outside of healthcare and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrate how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom line by demystifying the regulatory impact on operational requirements.

Details zur Ausgabe

• Verlag: Academic Press
• Erscheinungsdatum: 2022
• Sprache: Englisch
• ISBN 10: 0323911269
• ISBN 13: 9780323911269
• Einband: Taschenbuch
• Auflage: 1
• Anzahl der Seiten: 186
• Kontakt zum Hersteller: Academic Press; https://shop.elsevier.com/; ; 230 PARK AVENUE, SUITE 800; NY; NY; 10169; USA
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