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.
These two e-conferences on this topic are available onDemand:
A Walk Through the GHTF Clinical Evaluation Document -
Clinical Evaluation Reports
by Janette Benaddi. 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. Available OnDemand or on CD.
Notified Body Expectations for Clinical Evaluation Reports - From the British Standards Institute, Dr. Gert Bos and Dr. Suzie Halliday addressed Clinical Evaluation Reports from the Notified Body perspective on a e-conference on January 20, 2010. Now available OnDemand or on CD.
NJ Stark
Training
Books, e Conferences, workshops, and CDs or On Demand videos of past events.
Sign up for the Clinical Device Group News Letter- A Frequently Published Set of Links to Clinical Research News in the Device Industry.
Clinical Device Group recently wrote a whitepaper on clinical evaluation reports, you may have a free copy at