Clinical Evaluation Reports

Clinical Evaluation Reports for Medical Devices and the new MEDDEV 2.7/1 (rev 4)

Need to create or update your Medical Device Clinical Evaluation Reports? Published in June 2016 by the European Commission, MEDDEV 2.7/1 ‘Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC, the new guidance document is much more explicit on how to undertake a robust and systematic clinical evaluation, and how […]

Steps to promotion with Real Regulatory

Real Regulatory staff promotions

We are thrilled to announce several promotions within Real Regulatory. Dorothée Fouchier has been promoted to Managing Consultant of our Dublin office. Dorothée joined the company in 2006 and during her time with us she has managed Real Regulatory’s in-company and consulting services to provide clients with the strategic advice and guidance they need for […]