Certyfikat numer 60139365

Numer Certyfikatu: 60139365
Właściciel certyfikatu: DIGITHURST Bildverarbeitungssysteme
GmbH & Co. KG
Wasserrunzel 5
91186 Büchenbach
Niemcy
Zakres:

PACS-Software
Replaces Certificate, Registration No.: HD 60115317 0001

Standardy spełnione: Richtlinie 93/42/EWG
Typ Certyfikatu: Vollst. QMS, Anhang II MDD

EC declaration of conformity (Full quality assurance system)
Certificate according to Annex II Section 3 of the EC Directive 93/42/EEC concerning Medical Devices

The Notified Body hereby certifies the application of the quality system by the manufacturer approved for the design, manufacture and final inspection of the products concerned, as specified in Annex II, Section 3 of the EC directive 93/42/EEC.

The manufacturer is subject to audit as laid down in Sections 3.3 and 4 and to Community surveillance as specified in Section 5.

This approval can be used by the company in line with the declaration of conformity.