Risk classification guide for medical device establishment inspections GUI-0079

Risk classification guide for medical device establishment inspections GUI-0079 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, and assigning an overall compliance rating to an inspection. 2023-02-27 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyrisk classification guidemedical-device establishment inspectionsGUI-0079classifying observationsdeviationsdeficienciesfailurescompliance rating Risk classification guide for medical device establishment inspections GUI-0079HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/guidance-risk-classification-medical-device-observations-0079/document.html#a1 Risk classification guide for medical device establishment inspections GUI-0079HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/conformite-application-loi/information-produits-sante/instruments-medicaux/document-classification-risques-observations-instruments-medicaux-0079/document.html

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, and assigning an overall compliance rating to an inspection.

Data and Resources

Similar records