CDG: consulting, CRO contracting, and training for medical
devices and in vitro diagnostics. We do clinical research, contract research, biological safety, biocompatibility, and regulatory consulting.
We offer professional development, clinical trial workshops, and e conferences with guest expert speakers, both public and on-site.
In Europe, a clinical evaluation is always required The 2007 amendment to the European Medical Device Directive comes into force in March 2010, and it requires a full clinical evaluation (CE) to be conducted as part of the process to market a device. Since notified bodies will review the results of the evaluation, it is important that the clinical evaluation is conducted appropriately, correctly and robustly. The clinical evaluation determines whether or not a new clinical investigation is required. Clinical Device Group recently wrote a whitepaper on clinical evaluation reports, you may have a free copy at CE Report.
A Walk Through the GHTF Clinical Evaluation Document -
Clinical Evaluation Reports
by Janette Benaddi, 23 November 09. In this enjoyable and practical e-conference, we will use a case study to demonstrate how to conduct a step-by-step clinical evaluation according to the GHTF Clinical Evaluations document. We will use ISO 14155-1 (2003), GHTF SG5, and a flowchart of the process. Register now!
NJ Stark
Training
Books, e Conferences, workshops, and CDs or On Demand videos of past events.
Clinical Device Group recently wrote a whitepaper on clinical evaluation reports, you may have a free copy at