• There are no items in your cart

MEDDEV 2.1/6 : REV 1 : 2016

Current

Current

The latest, up-to-date edition.

QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE

Available format(s)

Hardcopy

Language(s)

English

Published date

01-07-2016

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

View more information
Free

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.