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Clinical Evaluations For Medical Devices Shalinee Naidoo

Name: Clinical Evaluations For Medical Devices Shalinee Naidoo
SKU: BELL-50318556
Price: 31.00 USD
Availability: InStock
Rating: 5 (88 reviews)

SKU: BELL-50318556

$ 31.00 ~~$ 45.00~~ (-31%)

5.0

88 reviews

Clinical Evaluations For Medical Devices Shalinee Naidoo instant download after payment.

Publisher: Arcler Press

File Extension: PDF

File size: 5.17 MB

Author: Shalinee Naidoo

ISBN: 9781774694145, 177469414X

Language: English

Year: 2022

Product desciption

Clinical Evaluations For Medical Devices Shalinee Naidoo by Shalinee Naidoo 9781774694145, 177469414X instant download after payment.

Being a medical device manufacturer involves more than just manufacturing of the device itself. It is also the manufacturers responsibility to ensure adequate research is done on the device so that it can be safely used. Clinical evidence is often collected throughout the entire life cycle of a medical device and is often an ongoing process. The process starts during the design and development of the device to show safety and efficacy and is often updated even after the device is on the market. This evidence is often compiled in a Clinical Evaluation Report and presents itself a chapter of the device technical file. As the medical industry continues to evolve, so does the complexity of clinical data needed during the regulatory approval process. This volume provides an introduction into the basic concepts of clinical evaluation report writing. Important concepts such as how to conduct a literature review, claiming equivalence and when to update your clinical reports are covered.