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Medical Device Directive SectionD
Seminar Series
Representation by an EU Authorized Representative
CE Dictionary
Harmonized Standards
EU Members
AIMDD Section
vigilance/Guidelines Classification_1 July 2001.pdf
vigilance/Guidelines Classification_2 July 2001.pdf
The AIMDD Directive
AIMDD Standards
download/Guidelines Vigilance 2.12-1rev4 April 2001.pdf
IVDD Section
Europe adopts IVD Directive
IVDD
IVDD - In Vitro Diagnostic Medical Device Directive
IVDD/ivd.pdf
IVDD Checklist: Essential Requirements
IVDD Checklist: Contents of a Device Master File
EEA
EDMS Codes
News and Information from the IVDD division of MDSS
Management & Personnel
About MDSS
MDD 93/42 EEC OVERVIEW OUTLINE
Contact MDSS
News and Information from MDSS, authorized representatives
Regulatory News and Views
Rgulatory news and Views
REGULATORY NEWS AND VIEWS from MDSS, authorized representatives
Meeting the Requirements of the IVD Directive
1999 News in European Regulatory Affairs from MMDSS, authorized representatives
List of Notified Bodies presented by MDSS, authorized representatives
German Notified Bodies
Confusion remains over legal status of CE Mark in Europe, Authorized representative MDSS reports
Contents of a Device Master File, presented by MDSS a ce mark authorized representative for EU
Labeling
CE Marking - Too burdensome for small manufacturers?
Importance of Being Authorized (Abstract)
CE Marketing for the mdical device industry
Medical Device Safety Service presents CE for Dummies
MDSS Seminar Series
Links
MDSS ADVISORY LINKS
Authorized Representative
EU Directives
Medical Devices Directives
DIRECTIVE 93/42/EEC
DIRECTIVE 90/385
Guidelines 90/385
Transitional Period
MEDDEV 2.5/5
MEDDEV 2.12/1
MEDDEV 2-1-3
MEDDEV 13/93
MEDDEV 5/93
Guidelines for the Classification of Medical Devices
Vigilance Guidelines
Class I medical devices with measuring function
MDD Reporting
Essential Requirements of the mdd 93/42 eec presented by Medical Device Safety Service
Publications
Welcome to Medical Device Safety Service In Vitro medical devices directive
Guidelines on a Medical Devices Vigilance System
Article 1
Harmonized Standards for Directive 93
MDSS Brochure
Interpreting the IVD
preamble and articles
Regulatory News & Views 1
Trade Show
AUGUST 2000 NEWS
Vigilance
Clients
EU Directives, Harmonized Standards and CE Dictionary presented by MDSS, a ce mark, ISO 9000, autorized representative and European regulatory affairs company
TUV Cert Certificate
Vigilance guidlines from MDSS for medical device industry and authorized representative support
ANNEX I
ANNEX II
ANNEX III
ANNEX IV
ANNEX V
ANNEX VI
ANNEX VII
ANNEX VIII
ANNEX IX
ANNEX X
ANNEX XI
ANNEX XII
flow chart 1
Flow Chart 2
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