Guidelines for Clinical Studies with Compression Devices in Patients with Venous Disorders of the Lower Limb

Author:

Rabe E.,Partsch H.,Jünger M.,Abel M.,Achhammer I.,Becker F.,Cornu-Thenard A.,Flour M.,Hutchinson J.,Ißberner K.,Moffatt Ch.,Pannier F.

Publisher

Elsevier BV

Subject

Cardiology and Cardiovascular Medicine,Surgery

Reference20 articles.

1. Conférence International de Consensus sur la Compression;Vin;Phlébologie,2003

2. DIN ISO EN 14155–1/-2: ‘Clinical investigation of medical devices for human subjects – Part 1: general requirements’. Part 2: clinical investigation plans’ (edited by Beuth Verlag, www.beuth.de).

3. ICH (International Conference of Harmonisation) e. g. Topic E 6: guideline for Good Clinical Practice in the European Community. (www.ich.org).

4. MEDDEV 2.7.1. April 2003 Clinical investigation, clinical evaluation, Guide for manufacturers and notified bodies.

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