TY  - BOOK
AU  - Naidoo,Shalinee
TI  - Clinical evaluations for medical devices / 
SN  - 9781774694145
AV  - R857.M3 
U1  - 610.28 
PY  - 2023///
CY  - Burlington, Ontario : 
PB  - Arcler Press, 
KW  - Medical instruments and apparatus
KW  - Evaluation
KW  - Medical technology
KW  - Regulation
KW  - Clinical trials
KW  - Methodology
KW  - Medical devices
KW  - Testing
N1  - Includes bibliographical references and index.; 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).
ER  -