Dear Readers,
Greetings!
Recently, we came across an interesting book for students and researchers in the field of Medical Devices & related clinical research.
We would like to share more details as the book is a unique compilation of all that is needed for a clinical research professional in Medical Devices. The drug and device differ in clinical science from various aspects, which are not only operations but also pragmatic. Missing regulatory harmonization and wide-spread diversity of the devices among the additional factors that add to the complexity of the still-developing device clinical requirements. Amid existence of this gross dependency on drug methodology for device clinical studies, there were continuing discussions in the industry about the need for describing a differentiated and distinguished process. Hence, over the years, requirements for drugs have evolved as significantly larger and better detailed than for medical devices, while medical device clinical studies continued to depend upon conventional retrofitting from drugs-oriented systems and methods. While there have been a few efforts from some authors, a few regulatory bodies, and some universal standards forums like CDISC and ISO, an end-to-end compilation of all that is needed in medical device clinical research was grossly missing before this book.
In this book, the overall clinical research requirements for medical devices are compiled from end-to-end. It has three main aspects, distributed over four parts. The first part is the basic concepts of medical devices and a small part on what are convergences and diversities between clinical research of drugs and devices. This part provides a high-level background of the regulatory process of market approval for medical devices, so that the research professional understands the purpose of the clinical research that they need to conduct. The second and third parts include scientific aspects of clinical research, including medical writing, data management, safety, medical coding, biostatistics and clinical operations. The fourth and the last part includes some extended applications in the rapidly changing medical device technology such as software as medical device (SaMD), software in medical device, diagnostic devices etc.
Author:
Dr. Ashish Indani
Expert Independent director| MedTech clinical Regulatory,
R&I| Key Opinion Leader in Medical Devices | Author | Tedx Speaker
Comments
Post a Comment