Clinical testing of a new medical device

Author:

Ramakrishna Seeram,Tian Lingling,Wang Charlene,Liao Susan,Teo Wee Eong

Publisher

Elsevier

Reference37 articles.

1. ClinicalTrials.gov—a service of the U.S. National Institues of Health. Retrieved January 26, 2015, from https://www.clinicaltrials.gov/.

2. Clinical studies for medical devices;Shayne Cox,2002

3. U.S. Food and Drug Administration, Case Study A stent company seeks to market a novel medical device-Bringing an innovative device to market: premarket approval (PMA) of medical devices. Retrieved November 05, 2014, from http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm404249.pdf, 2014.

4. U.S. Food and Drug Administration, Conducting Clinical Trials. Retrieved September 17, 2014, from http://www.fda.gov/drugs/developmentapprovalprocess/conductingclinicaltrials/default.htm, 2014.

5. Duncan Fatz, Guide to European Medical Device Trials and BS EN ISO 14155. UK: BSI Standards Limited; 2012.

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