Learning Resource and Development
Amazon cover image
Image from Amazon.com
Image from Coce

Clinical evaluations for medical devices / Shalinee Naidoo.

By: Material type: TextTextPublisher: Burlington, Ontario : Arcler Press, 2023Description: viii, 186 pages ; 24 cmContent type:
  • text
Media type:
  • unmediated
Carrier type:
  • volume
ISBN:
  • 9781774694145
Subject(s): DDC classification:
  • 610.28 N143c
LOC classification:
  • R857.M3
Contents:
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).
Tags from this library: No tags from this library for this title. Log in to add tags.
Holdings
Item type Current library Shelving location Call number Copy number Status Date due Barcode
Books Books Main Library Nursing Section NUR 610.28 N143c 2023 (Browse shelf(Opens below)) 1-1 Available 029437

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).

There are no comments on this title.

to post a comment.