S.R. CEN/TR 17223:2018
Current
Current
The latest, up-to-date edition.
GUIDANCE ON THE RELATIONSHIP BETWEEN EN ISO 13485: 2016 (MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES) AND EUROPEAN MEDICAL DEVICES REGULATION AND IN VITRO DIAGNOSTIC MEDICAL DEVICES REGULATION
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
01-01-2018
Publisher
National Foreword
European Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Relationship between the European Regulations
for Medical Devices and in vitro Diagnostic
Medical Devices and the clauses of EN ISO 13485
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