Clinical Evaluations for Medical Devices by Naidoo, Shalinee

Clinical Evaluations for Medical Devices

Being a medical device manufacturer involves more than just manufacturing of the device itself. It is also...
CHF 370.26
CHF 370.26
SKU: 9781774694145
Product Type: Books
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Author: Shalinee Naidoo
Format: Hardcover
Language: English
Subtotal: CHF 370.26
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Clinical Evaluations for Medical Devices by Naidoo, Shalinee

Clinical Evaluations for Medical Devices

CHF 370.26

Clinical Evaluations for Medical Devices

CHF 370.26
Author: Shalinee Naidoo
Format: Hardcover
Language: English
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.

Author: Shalinee Naidoo
Publisher: Arcler Press
Published: 12/01/2022
Binding Type: Hardcover
ISBN: 9781774694145

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