Clinical Device Group: A Medical Device Consultancy and CRO
Capabilities Sampler
Technology Sampler
• Marketing and claims assessment
Biocompatibility Safety Assessment
Device Biological Safety Reports (Movie)
Consultancy and CRO Capabilities
Regulatory Strategies n Submissions
Clinical Evaluations for the EU
Protocol Design, Study Design
• IVD Study Designs
Sample Size Calculations
Project Management for Clinical Studies
Regulation of Human Investigations
• Data Monitoring Boards
Data Management, Database Design
Statistical Analysis
Final Reports, Manuscripts
• 510(k) Submissions
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 Management (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
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Network Staff Associates
Judi Bednarz—market research
Dan McLain—toxicology
Bert Albers—cardiovascular regulations & investigations
Charles Hurwitz—clinical evaluations & other medical writing
Tim Brown—spine & orthopedics regulations & clinical evaluations
Brian Hartman—information specialist
Sunny Worel—information specialist
Kathleen Johnson—regulatory expert
Kathy Selover—regulatory expert
Michelle Secic—biostatistician
Robert Thiel—IVD & Bayesian statistics
Lynette Chiapperino—monitor, clinical project manager
Denise Baker—clinical evaluations & device quality systems
Sue Lesly—clinical study implementation
Patricia Hamilton—Latin & South American regulations & investigations
Steven Schurr—data monitoring committee management
Wessam Sonbol—database design
Todd Colbeth—data management
Vincent Jaeger—reimbursement specialist
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CDG Contact Information