MEDDEV 2.1/6 : REV 1 : 2016
Current
The latest, up-to-date edition.
QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE
Hardcopy
English
01-07-2016
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Introduction
1. Definitions and abbreviations
2. Qualification
3. Classification of stand alone software
4. Modules
Annex 1: Illustrative examples of qualification and
classification for software used in the healthcare
environment
Specifies the criteria for the qualification of stand alone software, when used in healthcare setting, as a medical device and the application of the classification criteria to such software.
| DevelopmentNote |
Available for free download. (01/2017)
|
| DocumentType |
Miscellaneous Product
|
| Pages |
29
|
| PublisherName |
European Union
|
| Status |
Current
|
| MEDDEV 2.7-2 : REV 2 | GUIDELINES FOR COMPETENT AUTHORITIES FOR MAKING A VALIDATION/ASSESSMENT OF A CLINICAL INVESTIGATION APPLICATION UNDER DIRECTIVES 90/385/EEC AND 93/42/EC |
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