Risk classification guide for medical device establishment inspections.: H14-327/2019E-PDF
"This document is intended to help ensure consistency among Health Canada inspectors during medical device establishment inspections when: classifying observations of deviations, deficiencies or failures according to risk; assigning an overall compliance rating to an inspection. It also informs anyone with a medical device establishment licence (MDEL) of the situations Health Canada considers unacceptable that may result in a non-compliant (NC) rating and/or compliance and enforcement actions"--page 5.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.873314&sl=0
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Risk classification guide for medical device establishment inspections. |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| Electronic document | |
| Note(s) | Issued also in French under title: Guide de classification des risques pour les inspections d'établissements d'instruments médicaux. "GUI-0079." "January 31, 2020." Issued also in HTML format. Includes bibliographical references (pages 27-28). |
| Publishing information | Ottawa, ON : Health Canada = Santé Canada, 2020. ©2020 |
| Description | 1 online resource (28 pages) |
| ISBN | 9780660309828 |
| Catalogue number |
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| Departmental catalogue number | 190053 |
| Subject terms | Medical instruments and apparatus -- Safety regulations -- Canada. |