Clinical Device Group: A Medical Device Consultancy and CRO
 NOTICE: Pardon our mess. Nancy is redesigning the website one page at a time. Since she is a newbie to html she is learning as she goes. Suggestions are welcome.
Capabilities Sampler Technology Sampler
• Marketing and claims assessment
Biocompatibility Risk Assessment
ISO 10993 Parts 1-20 Device Biological Safety
Sponsor Services
Regulatory Stategies n Submissions
Protocol Design, Study Design
• IVD Study Designs
Sample Size Calculations
Project Management for Clinical Studies
Regulation of Human Investigations
Monitoring
• Data Monitoring Boards
Data Management, Database Design
Statistical Analysis
Final Reports, Manuscripts
• 510(k) Submisstions
Site and Sponsor Audits
• Design Control Audits
• ISO 13485 Quality Mgmt Systems for Clinical Investigations
• ISO 14155 (Device Good Clinical Practice) Compliance
• ISO 14971 Risk Managerment (for Clinical Trials)


• Collagen implants
• Cardiovascular stents
• Cardiac re-synchronization
• Membrane oxygenation
• Arterial perfusion
• Deep brain stimulation
• Heart-lung machines, perfusion
• Wireless PDA operating systems
• Monoclonal antibody assays
• Direct-labeled probe assays
• ThinPrep Pap smear imaging
• Drug delivery devices
• Interventional cardiology
• Dental devices
• Bone growth stimulation, replacement
• External fixation devices
• Interventional cardiology
• Spinal implants
• Soft-tissue implants
• Imaging
• Lasers, YAG, Excimer, Cold
• Personal products
Network Staff Associates
Judi Bednarz—market research
Dan McLain—toxicology
Charles Hurwitz—medical writing
Brian Hartman—information specialist
Sunny Worel—information specialist
Kathleen Johnson—regulatory expert
Kathy Selover—regulatory expert
Gail Radcliffe—IVD expert
Michelle Secic—biostatistician
Robert Thiel—IVD & Bayesian statistics


Lynette Chiapperino—monitor, clinical project manager
Sue Lesly—clinical study implementation
Steven Schurr—data monitoring committee management
Wessam Sonbol—database design
Todd Colbeth—data management
Vincent Jaeger—reimbursement specialist 
CDG Whitepaper Contact Us
Request a Proposal 1-773-489-5706
CDG is possibly the oldest medical device clinical consultancy in the States, dating back to 1990. Organized like any other general contractor,our professional work is usually performed by independent experts. We understand medical device regulatory, biocompatibility, animal clinical and human clinical research, quality systems, and other device preapproval issues. Check out our brochure and our President's vitae.