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POST-MARKET SURVEILLANCE OF USE ERROR MANAGEMENT
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Available format(s): Hardcopy, PDF
Superseded date: 08-05-2020
Language(s): English
Published date: 01-01-2014
Publisher: Association for the Advancement of Medical Instrumentation
Glossary of equivalent standardsCommittee representationForeword1 Purpose2 Scope3 Terms and definitions4 How to use this document5 Background6 Regulatory focus on use error post-market surveillance7 Process recommendations for manufacturers8 Process recommendations for clinical usersAnnex A (informative) - Example questions for collecting use error or close call dataAnnex B (informative) - Connecting use error to customer complaintsBibliography
Covers the issue of use error detection for medical devices from the clinical, manufacturer, patient, user and regulatory perspective.
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