Clinical Trials and Training. Clinical Device Group Inc; Nancy Stark

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.