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Clinical Evaluations for Medical Devices by Shalinee Naidoo

Clinical Evaluations for Medical Devices

by Shalinee Naidoo
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Book cover type: Hardcover
  • ISBN13: 9781774694145
  • Binding: Hardcover
  • Subject: N/A
  • Publisher: Arcler Press
  • Publisher Imprint: Arcler Press
  • Publication Date:
  • Pages: 277
  • Original Price: USD 180.0
  • Language: English
  • Edition: N/A
  • Item Weight: 400 grams
  • BISAC Subject(s): General

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.

Shalinee Naidoo is currently the Regulatory and Product Development Manager of a medical device manufacturer based in South Africa. She is directly involved in global regulatory compliance and the design and development of new medical devices from idea conception to market. She is also the founder of Life of Shal (www.lifeofshal.com) an online travel journal created to inspire others to explore the world and Scientist's Sanctuary (www.scientistssanctuary.com) - a science communication company that specializes in bridging the gap between scientific knowledge and creative communication for both the academic and corporate world.

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