Leslie Dowling receives Distinguished Service Award from TOPRA - present by Bob Clay. Photo courtesy of TOPRA

Real Regulatory News – Leslie Dowling receives TOPRA Distinguished Service Award

Congratulations to our colleague Leslie Dowling who recently received a Distinguished Service Award from TOPRA. Being a well-practiced multitasker,  Leslie also heads up our UK office as Managing Consultant. Having worked in regulatory affairs since 1997, mainly in human medicines, but also encompassing medical devices and veterinary medicines, Leslie is experienced in managing multiple regulatory […]

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 […]