CDG — Consulting, contracting, and training for medical devices.

Gantt chart for a typical clinical research trial; tasks are plotted against time. Click on a task to see how CDG can help you.   
Biological Safety Biologycal Safety
Market Assessment Market Assessment
Regulatory strategy Regulatory Strategy
Protocol Protocol
Sample size Sample Size
Case report form design Case Report Form Design
Investigator Agreement INvestigators Agreement    
Budget & payment terms Budget and payment terms
Clinical Trials Agreement Clinical Trials Agreement
IRB Review & approval IRB Review and approvalmilestone1  
Initiation, first subject in milestone2
Monitoring close-out las subject out  
Close-out, last subject out milestone3
Database Design Database Design
Data entry, queries Statistical analysismilestone4  
Statistical analysis Regulatory submission, approval  
Regulatory Submission, approval Medical device to market  
TO MARKET

milestone5

Project Management
Training

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cdginc@clinicaldevice.com

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.CER Timeline 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.

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