Naidoo, Shalinee, <br/><br/>
Clinical evaluations for medical devices /  
Shalinee Naidoo.  
 - viii, 186 pages ;  24 cm.  
<br/><br/>Includes bibliographical references and index.  
<br/><br/>What is a clinical evaluation report (CER) -- Understanding MEDDEV 2.7/1 (Revision 04) in greater detail: MEDDEV 2.7/1 (REV 4) - Clinical evaluation: a guide for manufacturers and notified bodies under directives 93/42 EEC and 90/385/EEC -- Essential requirements (ERs) of medical devices (Under the MDD 93/42 EEC) -- General safety and performance requirements (GSPRs) of medical devices (under the MDR 2017/745) -- Claiming equivalent between medical devices -- MDCG 2020-5: Clinical evaluation - equivalence: a guide for manufacturers and notified bodies -- Differences in technical, biological, and chemical characteristics -- Demonstration of equivalence -- Use of data from similar devices -- How to conduct a literature review -- When to update your CER -- What is a clinical evaluation plan -- Post-market clinical follow-up (PMCF).  
<br/><br/><label>ISBN: </label>9781774694145 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Medical instruments and apparatus --Evaluation.<br/>Medical technology--Regulation.<br/>Clinical trials--Methodology.<br/>Medical devices--Testing.
<br/><br/><label>LC Class. No.: </label>R857.M3 
<br/><br/><label>Dewey Class. No.: </label>610.28  / N143c