01886nam a2200301 i 4500 CSPC 20250430163118.0 250423s2023 onc b 001 0 eng d 9781774694145 CSPC CSPC eng rda R857.M3 610.28 N143c Naidoo, Shalinee, author. Clinical evaluations for medical devices / Shalinee Naidoo. Burlington, Ontario : Arcler Press, 2023. viii, 186 pages ; 24 cm. text rdacontent unmediated rdamedia volume rdacarrier 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). Medical instruments and apparatus Evaluation. Medical technology Regulation. Clinical trials Methodology. Medical devices Testing. ddc 0 BK 610.28 N143c NUR 2023 0 0 ddc 0 0 CSPC CSPC NUR 2025-04-23 0 NUR 610.28 N143c 2023 029437 2025-04-23 13:09:11 1-1 2025-04-23 BK 29473 29473