Learning Resource and Development

Clinical evaluations for medical devices / (Record no. 29473)

MARC details
000 -LEADER
fixed length control field 01886nam a2200301 i 4500
003 - CONTROL NUMBER IDENTIFIER
control field CSPC
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20250430163118.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 250423s2023 onc b 001 0 eng d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781774694145
040 ## - CATALOGING SOURCE
Transcribing agency CSPC
Original cataloging agency CSPC
Language of cataloging eng
Description conventions rda
050 04 - LIBRARY OF CONGRESS CALL NUMBER
Classification number R857.M3
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 610.28
Item number N143c
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Naidoo, Shalinee,
Relator term author.
245 10 - TITLE STATEMENT
Title Clinical evaluations for medical devices /
Statement of responsibility, etc. Shalinee Naidoo.
264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE
Place of production, publication, distribution, manufacture Burlington, Ontario :
Name of producer, publisher, distributor, manufacturer Arcler Press,
Date of production, publication, distribution, manufacture, or copyright notice 2023.
300 ## - PHYSICAL DESCRIPTION
Extent viii, 186 pages ;
Dimensions 24 cm.
336 ## - CONTENT TYPE
Content type term text
Source rdacontent
337 ## - MEDIA TYPE
Media type term unmediated
Source rdamedia
338 ## - CARRIER TYPE
Carrier type term volume
Source rdacarrier
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc. note Includes bibliographical references and index.
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note 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).
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Medical instruments and apparatus
General subdivision Evaluation.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Medical technology
General subdivision Regulation.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Clinical trials
General subdivision Methodology.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Medical devices
General subdivision Testing.
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme Dewey Decimal Classification
Suppress in OPAC No
Koha item type Books
Classification part 610.28
Item part N143c
Call number prefix NUR
Call number suffix 2023
Holdings
Withdrawn status Lost status Source of classification or shelving scheme Damaged status Not for loan Home library Current library Shelving location Date acquired Total Checkouts Full call number Barcode Date last seen Copy number Price effective from Koha item type
    Dewey Decimal Classification     Main Library Main Library Nursing Section 04/23/2025   NUR 610.28 N143c 2023 029437 04/23/2025 1-1 04/23/2025 Books